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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D. C. 20549

____________

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act Of 1934

 

September 11, 2017

Date of Report (Date of earliest event reported)

___________________________________________________________

 

ACURA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Charter)

___________________________________________________________

 

State of New York  1-10113  11-0853640
(State of Other Jurisdiction  (Commission File Number)  (I.R.S. Employer
of Incorporation)     Identification Number)

 

616 N. North Court, Suite 120

Palatine, Illinois 60067

(Address of principal executive offices) (Zip Code)

 

(847) 705-7709

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17CFR240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e- 4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging Growth Company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 7.01Regulation FD Disclosure.

 

Robert Jones, our President and Chief Executive Officer, will present at the 19th Annual Rodman & Renshaw Global Investment Conference on Monday, September 11, 2017 at 1:45 p.m. Eastern Time. The conference is being held at the Lotte New York Palace Hotel, New York, New York. Slides from the presentation are attached hereto as Exhibit 99.1.

 

Statements in the investor slide presentation that are not strictly historical may be “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Forward-looking statements may include, but are not limited to:

 

·our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITx™ and Impede® technologies;

 

·the expected results of clinical studies relating to LTX-04 or any successor product candidate, the date by which such study will complete and the results will be available and whether LTX-04 or any successor product candidate will ultimately receive FDA approval;

 

·whether LIMITx will retard the release of opioid active ingredients as dose levels increase;

 

·whether we will be able to reformulate LTX-04 or any successor product candidate to provide an efficacious level of drug when one or two tablets are taken;

 

·whether a reformulated LIMITx formulation that achieves an efficacious level of drug will continue to demonstrate acceptable abuse deterrent performance;

 

·whether we will be able to reformulate LTX-04 or any successor product candidate to improve its abuse deterrent performance;

 

·whether the results from LTX-04 studies will translate into similar results for an immediate release hydrocodone bitartrate acetaminophen product, which is the product we intend to take forward in the near term;

 

·whether the FDA will accept delays in gastric emptying as a viable component of abuse deterrent methodology;

 

·whether the extent to which products formulated with the LIMITx technology deter abuse will be determined sufficient by the FDA to support approval or labelling describing abuse deterrent features;

 

 

 

 

·our and our licensee’s ability to successfully launch and commercialize our products and technologies, including Oxaydo® Tablets and Nexafed® products;

 

·our and our licensee’s ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;

 

·the market acceptance of, timing of commercial launch and competitive environment for any of our products;

 

·our ability to develop and enter into additional license agreements for our product candidates using our technologies;

 

·the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;

 

·the ability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation;

 

·the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support FDA approval of our product candidates;

 

·changes in regulatory requirements;

 

·adverse safety findings relating to our commercialized products or product candidates in development;

 

whether the FDA will agree with our analysis of our clinical and laboratory studies;

 

·whether further studies of our product candidates will be required to support FDA approval;

 

·whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications and whether we will be able to promote the features of our abuse discouraging technologies; and

 

·whether Oxaydo or our Aversion® and LIMITx product candidates will ultimately deter abuse in commercial settings and whether our Nexafed products and Impede technology product candidates will disrupt the processing of pseudoephedrine into methamphetamine.

 

In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential" and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in our filings with the Securities and Exchange Commission.

 

 

 

 

Item 8.01Other Events.

 

On September 11, 2017 we issued a press release announcing the results of the previously undisclosed exploratory arm of our second LIMITx™ clinical study, study AP-LTX-401 (Study 401). A copy of the press release is attached as Exhibit 99.2.

 

Item 9.01Financial Statements and Exhibits.

 

Exhibit  
Number Description
   
99.1 Slides from the Scheduled Presentation on September 11, 2017
   
99.2 Press Release of September 11, 2017

 

 

 

  

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  ACURA PHARMACEUTICALS, INC.  
       
       
  By: /s/ Peter A. Clemens  
    Peter A. Clemens  
    Senior Vice President & Chief Financial Officer
       
Date: September 11, 2017      

 

 

 

 

Exhibit  
Number Description
   
99.1 Slides from the Scheduled Presentation on September 11, 2017
   
99.2 Press Release of September 11, 2017

 

 

 

 

Exhibit 99.1

 

CONFIDENTIAL Symbol: ACUR September 2017 Rodman & Renshaw Conference © 2017 Acura Pharmaceuticals, Inc. All Rights Reserved

 

 

Symbol: ACUR General Caution Regarding Forward Looking Statements Certain statements in this presentation constitute “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 . Such forwarding - looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward - looking statements . These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties . Given these uncertainties, you should not place undue reliance on these forward - looking statements . We discuss many of these risks in greater detail in our filings with the Securities and Exchange Commission . Unless required by law, we undertake no obligation to update or revise any forward - looking statements to reflect new information or future events or developments . Forward - looking statements may include, but are not limited to: • the ability to fund, or obtain funding, for our continuing operations; • the ability to enter into future partnerships or maintain our current partnerships; • the results and timing of future development efforts, whether the FDA will accept those results and completeness of our studies, whether FDA will approve the products for marketing, and whether our technologies will actually reduce abuse if marketed ; • the ability to reformulate our lead LIMITx product candidate, including to increase blood levels with 1 or 2 tablets while maintaining its abuse deterrent effects; • the ability of our technologies, if approved, to be successfully marketed, including distribution, market acceptance, market share penetration, and the pricing and price discounts that may be offered; • exposure to infringement of patents, trademarks and other proprietary rights of third parties; and • the ability of our patents to protect our products from generic competition. 2

 

 

Symbol: ACUR Acura’s Abuse Deterrent Technology Platforms  Opioid Abuse – Oral Excessive Tablet Abuse  Exploratory Stage Development  Un - partnered  Issued US Patents to 2033  Pseudoephedrine – Conversion to Meth  Two US Marketed Nexafed® Products  License to MainPointe Pharma  Issued US Patents to 2032  Opioid Abuse – Snorting and Injection  Oxaydo ® FDA Approved with labeling  Licenses to Egalet and Kempharm  Issued US Patents to 2025 3

 

 

Symbol: ACUR • April 2015 FDA Guidance “Abuse Deterrent Opioid – Evaluation and Labeling” • Immediate - release opioids containing acetaminophen (APAP) • Predominately abused by the oral route • Addressing nasal abuse may not meaningfully reduce abuse • July 2017 Prime Therapeutics Press Release • “.. we remain concerned about overprescribing of ADF opioids, especially when they can still be used in excess quantities…” • August 2017 Investigator for the VA Center for Health Equity Research and Promotion • “ These products [current abuse deterrent opioids] do not prevent the most common form of opioid abuse — ingesting pills orally in a way that isn’t consistent with the actual prescription .” • August 2017 Dr. Scott Gottlieb, FDA Commissioner • [FDA] wants to focus on reducing the chance people get addicted in the first place 4 A Need for Oral Excessive Tablet Abuse Technologies

 

 

Symbol: ACUR LIMITx ™ Benefits (Unsolicited) As identified by o pioid prescribers 5 Source: Company Physician Focus Groups; n=8

 

 

Symbol: ACUR Illustration The LIMITx ™ Technology Product Formulation • Micro - particles containing the opioid active ingredient • Functional tablet matrix of other ingredients Oral Abuse Deterrence • Tablet matrix acts synergistically with the micro - particle ingredients to retard the release of micro - particle active ingredients when multiple tablets are ingested Nasal Abuse Deterrence • Micro - particles can not be reduced/tampered due to size • Micro - particles designed to be insoluble in the nasal environment IV Abuse Deterrence • Multi - step process is expected to be required to extract opioid for syringing 6

 

 

Symbol: ACUR OBJECTIVES #1 To provide meaningful analgesic blood levels of drug at the recommended single tablet dose #2 To reduce the peak drug levels in the blood when more than the recommended dose is ingested LIMITx ™ Technology Objectives 7 CHALLENGES #1 : Find the appropriate buffer level that allows for complete release of the drug in the micro - particle with one tablet #2 : Design a micro - particle that does not release drug in a non - acidic gastric environment x 

 

 

Symbol: ACUR • LTX - 04 – Immediate - Release Hydromorphone HCl Tablets • Fasted Pharmacokinetic Studies AP - LTX - 400 and AP - LTX - 401 • Studied 1 tablet up to 8 and 7 tablets, respectively LIMITx ™ Studies To Date 8 Formulation Tested Clinical Study Micro - particle Release Buffer Strength LTX - 04S 400 Slower (MP17) Lower LTX - 04P 400 Slower (MP17) Higher LTX - 04P3 401 Faster (MP25) Higher

 

 

Symbol: ACUR 9 Study 401 Micro - particles are much faster at pH 2 0 20 40 60 80 100 0 5 10 15 20 % HM in Solution Time (minutes) Dilaudid MP17-slower MP25-faster MP17 used in Study 400 MP25 used in Study 401 Mean fasted gastric pH is 1.3 to 2.1 In Vitro Dissolution in pH2 HCl

 

 

Symbol: ACUR 10 One Tablet LTX - 04 Dose Cmax is Consistent 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 Plasma Conc. Ng/mL DILAUDID LTX-04S LTX-04P Study 400 (n=8) even when the buffer strength and micro - particle release vary 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 Plasma Conc. Ng/mL HYMP LTX-04P3 Study 401 (n=27) - 45% - 50% - 48% Lower Higher Buffer Higher Slower Slower Micro - particle Faster

 

 

Symbol: ACUR 11 Study 401 Micro - particles Limit Release at pH 7 0 20 40 60 80 100 0 30 60 90 120 % HM in Solution Time (minutes) Dilaudid MP17-slower MP25-faster MP17 used in Study 400 MP25 used in Study 401 Mean fasted gastric pH is 1.3 to 2.1 In Vitro Dissolution in pH7 Water

 

 

Symbol: ACUR 12 Multi - Tablet LTX - 04 Dose Cmax is further reduced 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 Plasma Conc. Ng/mL HYMP LTX-04P3 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 Plasma Conc. Ng/mL DILAUDID LTX-04P Study 400 (n=8) Study 401 (n=13) 7 Tabs Normalized 8 Tabs Normalized as more buffering agent is ingested - 65% - 59% Higher Buffer Higher Slower Micro - particle Faster

 

 

Symbol: ACUR -80% -60% -40% -20% 0% Increasing Tablets [Buffer] Impact on Cmax / Tmax 13 -40% -20% 0% 20% 40% Study 400 % Change LTX - 04P versus DILAUDID Cmax by No. of Tabs T max by No. of Tabs 1 2 3 4 6 8 1 2 3 4 6 8 Gastric pH readings in Study 400 provided acid neutralization onset and duration for a 3 tablet dose. The data Indicates the duration of acid neutralization was the same for doses from 3 through 8 tablets.

 

 

Symbol: ACUR 14 Gastric Emptying Plays a Role in Delaying Drug Release 0.00 0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 Tmax (hrs) HYMP LTX-04P3 LTX-04P3 w/ GE agent • Study 401 – 7 tablet dose • Agent introduced to increase gastric emptying time (Increase gastric retention time) Tmax is significantly increased when gastric emptying is delayed Geometric Mean

 

 

Symbol: ACUR 15 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 Cmax (ng/mL) HYMP LTX-04P3 LTX-04P3 w/ GE Agent • Study 401 – 7 tablet dose • Agent introduced to increase gastric emptying time (Increase gastric retention time) Despite a lengtehened Tmax with the GE Agent, Cmax for LTX - 04 remains consistent suggesting micro - particles rapidly and fully released after gastric re - acidification. Delayed LTX - 04 Tmax does not impact Cmax Geometric Mean

 

 

Symbol: ACUR • LTX - 04 (Studies 400 and 401 Conclusions) • We believe the micro - particles are working as designed: • The clinical data to date indicates we can manipulate the extent and duration of the gastric environment which controls the release and absorption of the active ingredient • The rapid release of the micro - particles upon gastric re - acidification suggests that we have excessive buffer strength in the tablets which needs to be fine tuned. • LTX - 03 (Next Steps) • Hydrocodone Bitartrate with Acetaminophen • Study AP - ADF - 300 Buffer Dose Ranging Study • Design final tablet formulation with appropriate buffer strength • Move to commercial supply for NDA clinical work LIMITx ™ Conclusions and Next Steps 16 x 

 

 

Symbol: ACUR Immediate Release Opioids Market Opportunity 2016 Addressable Market (millions) Immediate - release Opioid Reference Brand(s) TRx Tablets Dollars Price/ Tab* Hydrocodone/APAP Vicodin, Norco 88.7 5,433 888 .16 Oxycodone/APAP Percocet 35.1 2,224 841 .38 Oxycodone Roxicodone 20.1 1,775 359 .20 Tramadol Ultram 41.3 3,068 66 .02 Hydromorphone Dilaudid 3.2 253 42 .17 Morphine 1.5 129 21 .16 Oxymorphone Opana .2 21 45 2.14 Total Addressable Market 190.1 12,903 2,262 *Average - Principally generic pricing with pricing leverage for differentiated products 17

 

 

Symbol: ACUR 18 Study AP - LTX - 300 Design 56 subjects enrolled 8 Subj. 1 Norco® 8 Subj. LTX - 03 + 0 Buffer 8 Subj. LTX - 03 + 1 Buffer 8 Subj. LTX - 03 + 2x Buffer 8 Subj. LTX - 03 + 3x Buffer 8 Subj. LTX - 03 + 4x Buffer 8 Subj. LTX - 03 + 5x Buffer Norco = Hydrocodone Bitartrate/APAP 10/325mg tablet LTX - 03 = Hydrocodone MP with APAP 10/325mg dose Buffer = Buffer strength dose at a fraction of that studies in Studies 400 and 401 Doses will be over - encapsulated Parallel design – one dose visit per subject Pharmacokinetic outcomes Topline results – expected Oct . 2017

 

 

Symbol: ACUR 19 Acura’s Other Technologies Aversion® Opioid Analgesic • FDA approved ( Oxaydo ®) • Differentiated abuse deterrent label (snorting) • Oxaydo ® Licensed worldwide to Egalet Corp. • Stepped Royalties • Aversion® licensed to Kempharm for their prodrugs • Royalty Impede® Pseudoephedrine Nasal Decongestant • Nexafed® licensed to MainPointe Pharma (US/Canada) • 7.5% Royalty • Acura finishing development of PSE/ Loratadine with Impede® ®

 

 

Symbol: ACUR Acura Pharmaceuticals Summary 20

 

 

Symbol: ACUR 21 AVERSION® Immediate - Release Opioids NEXAFED® with IMPEDE® (Pseudoephedrine (PSE)) 30mg Tablets Sinus Pressure + Pain Oxaydo® (oxycodone HCl) 7 Opioid Formulations 12 Hour PSE/ Loratadine LIMITX™ Immediate - Release O pioids LTX - 04 LTX - 03 Formulation & Stability Clinical & Lab Testing NDA Submitted Approval/ Marketed Acura Product Pipeline Overview Active Development

 

 

Symbol: ACUR • Limitx™ Technology: U.S. issued patents expire 2033 • 3 U.S. patents issued • 9,101,636 - 9,320,796 - 9,662,393 • Patents issued in selected foreign jurisdictions • Aversion® Technology: U.S. issued patents expire 2023 to 2025 • 6 U.S. patents issued • US Generic market entry January 2022 • Patents issued in selected foreign jurisdictions • Impede® Technology: U.S. issued patent expires 2032 • 1 U.S. patent issued • Additional U.S. and foreign patents pending for all technologies Intellectual Property Position 22

 

 

Symbol: ACUR • Limitx™ Technology • Results from Study AP - LTX - 300 expected October 2017 • Determine commercial LTX - 03 formulation • Commence LTX - 03 NDA studies in 2018 • Evaluate LIMITx ™ for additional drug classes • Complete formulation work on PSE/ Loratadine in first half 2018 • Pursue further licensing/partnering opportunities • Sufficient cash to execute current business plan through Q1 2018 Expectations for 2017 23

 

 

CONFIDENTIAL Symbol: ACUR Acura Pharmaceuticals, Inc. 616 N. North Court, Suite 120 Palatine, IL 60067 (847) 705 - 7709 www.AcuraPharm.com

 

Exhibit 99.2

 

 

 

Acura Pharmaceuticals Presenting New LIMITx™ Clinical Data
at the 19th Annual Rodman & Renshaw Conference

PALATINE, Ill, September 11, 2017: Acura Pharmaceuticals, Inc. (OTCQB: ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced the results from the previously undisclosed exploratory arm of its second LIMITx™ clinical study, study AP-LTX-401 (Study 401). Bob Jones, President and Chief Executive Officer, will present the results at the 19th Annual Rodman & Renshaw Global Investment Conference today at 1:45 p.m. Eastern Time. The presentation will be webcast live and may be accessed by visiting Acura’s website at www.acurapharm.com.

 

Study 401 dosed fasted subjects with 7 tablets of LTX-04P3, a test version of Acura’s LTX-04 LIMITx oral excessive tablet abuse deterrent technology with a comparison to 7 tablets of commercially available comparable hydromorphone hydrochloride tablets. The exploratory arm added an ingredient, simultaneously dosed with 7 LTX-04P3 Tablets, known to delay gastric emptying and to potentially increase the retention of the LIMITx buffering ingredients in the stomach.

 

The exploratory arm demonstrated an increase in time to maximum concentration of drug in the bloodstream (lnTmax) to slightly over 2 hours compared to 43 minutes for hydromorphone and 73 minutes for LTX-04P3 alone. Peak concentration of drug in the bloodstream (lnCmax) for the exploratory arm was 3.74 ng/mL compared to 6.73 for hydromorphone and 2.49 for LTX-04P3 alone.

 

The 7 tablet cohort in Study 401 was a crossover pharmacokinetic design in fasted, healthy adult subjects. 30 subjects completed the hydromorphone arm, 13 subjects completed the LTX-04P3 arm, and 15 subjects completed the LTX-04P3 exploratory arm. There were no serious adverse events with adverse events observed consistent with those known to be associated with hydromorphone.

 

The patented LIMITx technology works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed and relies on stomach acid to play a role in the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the tablets.

 

About Acura Pharmaceuticals

Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITx™, AVERSION® and IMPEDE® Technologies. LIMITx contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.

 

OXAYDO® (oxycodone HCl immediate-release tablets) which incorporates the AVERSION Technology, is FDA approved and marketed in the U.S. by our partner Egalet Corporation.

 

NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology, are marketed in the U.S. by our partner MainPointe Pharmaceuticals.

 

 

 

 

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Forward-looking statements may include, but are not limited to:

 

·our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITx and Impede® technologies;
·the expected results of clinical studies relating to LTX-04 or any successor product candidate, the date by which such study will complete and the results will be available and whether LTX-04 or any successor product candidate will ultimately receive FDA approval;
·whether LIMITx will retard the release of opioid active ingredients as dose levels increase;
·whether we will be able to reformulate LTX-04 or any successor product candidate to provide an efficacious level of drug when one or two tablets are taken;
·whether a reformulated LIMITx formulation that achieves an efficacious level of drug will continue to demonstrate acceptable abuse deterrent performance;
·whether we will be able to reformulate LTX-04 or any successor product candidate to improve its abuse deterrent performance;
·whether the results from LTX-04 studies will translate into similar results for an immediate release hydrocodone bitartrate acetaminophen product, which is the product we intend to take forward in the near term;
·whether the FDA will accept delays in gastric emptying as a viable component of abuse deterrent methodology;
·whether the extent to which products formulated with the LIMITx technology deter abuse will be determined sufficient by the FDA to support approval or labelling describing abuse deterrent features;
·our and our licensee’s ability to successfully launch and commercialize our products and technologies, including Oxaydo® Tablets and our Nexafed® products;
·our and our licensee’s ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;
·the market acceptance of, timing of commercial launch and competitive environment for any of our products;
·our ability to develop and enter into additional license agreements for our product candidates using our technologies;
·the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;
·the ability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation;
·the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support FDA approval of our product candidates;
·changes in regulatory requirements;
·adverse safety findings relating to our commercialized products or product candidates in development;
·whether the FDA will agree with our analysis of our clinical and laboratory studies;
·whether further studies of our product candidates will be required to support FDA approval;
·whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications and whether we will be able to promote the features of our abuse discouraging technologies; and
·whether Oxaydo or our Aversion and LIMITx product candidates will ultimately deter abuse in commercial settings and whether our Nexafed products and Impede technology product candidates will disrupt the processing of pseudoephedrine into methamphetamine.

 

 

 

 

In some cases, you can identify forward- looking statements by terms such as "may," “will”, "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," “indicates”, "projects," predicts," "potential" and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in our filings with the Securities and Exchange Commission.

 

Contact:

for Acura Investor Relations

investors@acurapharm.com

847-705-7709