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
July 13, 2016
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 of Incorporation) |
(Commission File Number) |
(I.R.S. Employer 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 (17 CFR 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))
| Item 7.01 | Regulation FD Disclosure. |
On July 14, 2016, we will hold a webcast at 8:30 am ET to discuss additional data from Study AP-LTX-400, a pharmacokinetic study in healthy subjects of hydromorphone hydrochloride immediate-release tablets using the Company’s new LIMITX™ oral abuse deterrent technology. The slides to be discussed on the webcast are attached as Exhibit 99.1.
Forward-Looking Statements
Statements in the attached exhibit 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:
· the expected results of clinical studies relating to LTX-04P, the date by which such study results will be available and whether LTX-04P 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-04P to provide an efficacious level of drug when one or two tablets are taken;
· 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;
· whether our LIMITX technology can be expanded into extended-release formulations;
· our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITX and Impede® technologies;
· 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;
· expectations regarding potential market share for 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 ability to fulfill the FDA requirements for approving our product candidates for commercial manufacturing and distribution in the United States, including, without limitation, the adequacy of the results of the laboratory and clinical studies completed to date, the results of laboratory and clinical studies we may complete in the future to support FDA approval of our product candidates and the sufficiency of our development process to meet over-the-counter (“OTC”) Monograph standards, as applicable;
· 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.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit Number | Description |
| 99.1 | Slides for July 14, 2016 Webcast |
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: July 13, 2016
EXHIBIT INDEX
| Exhibit Number | Description |
| 99.1 | Slides for July 14, 2016 Webcast |
Exhibit 99.1
July 14, 2016 Study AP - LTX - 400 Subject Level Review © 2016 Acura Pharmaceuticals, Inc. All Rights Reserved
2 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 expected results of clinical studies relating to our LTX - 04 formulation, the date by which such study results will be available and whether LTX - 04 will ultimately receive FDA approval; • whether LTX - 04 will retard release of the active ingredients as dose levels increase; • whether we will be able to reformulate LTX - 04 to provide increased blood level at a 1 or 2 tablet dose or improve its abuse deterrent effects ; • whether our Limitx™ technology can be expanded to extended - release products; • 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 our development efforts, whether the FDA will agree with or 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; and • exposure to infringement of patents, trademarks and other proprietary rights of third parties.
3 Study 400 – Subject Level Review • Outcomes of pH data review • Review of Study 400 Subject Level data • Identification of key patient populations • Conclusions • Next Steps for the LTX - 04 Development Program
4 Study 400 – Design 60 subjects enrolled 10 taking 6 tablets 10 taking 4 tablets 10 taking 8 tablets 9 Complete 8 Complete 8 Complete Cohort 2 10 taking 2 tablets 10 taking 1 tablet 10 taking 3 tablets 10 Complete 8 Complete 8 Complete Cohort 1
5 Study 400 – Objectives Objectives: • Demonstrate LIMITX technology can retard the release of the active ingredient as 3 or more doses are administered in humans • Demonstrate the LTX - 04 formulation achieves blood levels of drug with 1 and/or 2 tablets equivalent to DILAUDID Topline (Dosing Group) Results: • LTX - 04P Tmax and AUC 0 - inf was approximately the same as DILAUDID • At 1 and 2 tablets, LTX - 04P Cmax was approximately 50% of DILAUDID • LTX - 04P demonstrated an average 22% proportional reduction in maximum plasma concentration ( Cmax ) of active drug compared to non - LIMITX tablets when 3, 4, 6 and 8 tablets were ingested
6 Study 400 – Cmax Change by Subject • Since the Cmax of LTX - 04P as a group is 53% of DILAUDID, for comparison purposes each subject’s LTX - 04P was adjusted based on the 1 and 2 tablet group average. • To be conservative, each subject’s Cmax of LTX - 04P was multiplied by 2x to compute a percent change versus Dilaudid 2.1x 1.9x 1.7x * Dose adjusted by dividing the Cmax by the number of tablets
7 3, 4, 6 & 8 Tablet Completers Study 400 – % Change in Cmax by Tmax • 58% (19 of 33 subjects) had a reduction in Cmax • 74% (14 of the 19) had a Diluadid Tmax of 30 minutes or less
8 3, 4, 6 & 8 Tablet Completers Study 400 – % Change in Cmax by Tmax • Further analysis identifies a “Faster” absorber group ( Dilaudid Tmax of 30 minutes or less) and a “Slower absorber group • 17 subjects are in the Faster Group and 16 in the Slower Group FASTER Group SLOWER Group
9 Study 400 – The Faster Group are higher absorbers 3,4,6 & 8 Tablet Completers C max * (ng/mL) Group Faster mean (SD) Slower mean (SD) Dilaudid 1.97 (1.25) 1.07 (.63) 1.8x LTX - 04P x 2 1.21 (.44) 1.14 (.46) 1.1x N 17 16 Minimum 0.64 0.50 1.3x Median 1.53 0.98 1.6x Maximum 5.27 1.98 2.7x * Dose Adjusted Cmax = Cmax divided by number of tablets dosed SD = Standard Deviation • Cmax for the Faster Group is almost 2x higher than for the Slower Group • The Faster Group may be more a more vulnerable patient population since Tmax is faster and Cmax is higher
10 Study 400 – Distribution of Cmax Change
11 3,4,6 & 8 Tablet Completers Tmax of Dilaudid (hours) Group Faster mean (SD) Slower mean (SD) All mean SD Dilaudid 0.49 (.06) 1.03 (.37) 0.75 (.38) LTX - 04P 0.79 (.51) 0.77 (.73) 0.78 (.63) n 17 16 33 SD=Standard Deviation Study 400 – Tmax Extended for the Faster Group • Tmax for the Faster Group was extended • Tmax for Slower Group was within expectations
12 Study 400 – Subject Level Conclusions Lengthening of the Tmax for the Faster Absorber Group again confirms that the LIMITx concept works The LTX - 04P showed its best effectiveness in the Faster Absorber Group exhibiting: - 82% of subjects had an estimated reduction in Cmax - 38% average estimated reduction in Cmax - 66% maximum reduction in estimated Cmax - 1.6x average increase in Tmax Results consistent with the suspected mechanism of LIMITx Faster absorbers also tend to have a higher Cmax , which may make this population particularly vulnerable to overdoses of hydromorphone x x x x
13 • Reformulation of micro - particles for faster release continues • Meet with FDA under FAST TRACK • Expect to run the next clinical study in 4Q 2016 LTX - 04 Path Forward
Acura Pharmaceuticals, Inc. 616 N. North Court, Suite 120 Palatine, IL 60067 (847) 705 - 7709 www.AcuraPharm.com www.Nexafed.com www.Oxaydo.com