# EDGAR Filing Document

**Accession Number:** 0000786947
**File Stem:** 0001104659-23-009872
**Filing Date:** 2023-2
**Character Count:** 11881
**Document Hash:** f4cac7c41163267a160899caec4bb9d2
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-009872.hdr.sgml**: 20230202

**ACCESSION NUMBER**: 0001104659-23-009872

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20230202

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20230202

**DATE AS OF CHANGE**: 20230202

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ACURA PHARMACEUTICALS, INC
- **CENTRAL INDEX KEY:** 0000786947
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 110853640
- **STATE OF INCORPORATION:** NY
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-10113
- **FILM NUMBER:** 23580658

**BUSINESS ADDRESS:**
- **STREET 1:** 616 N. NORTH COURT, SUITE 120
- **CITY:** PALATINE
- **STATE:** IL
- **ZIP:** 60067
- **BUSINESS PHONE:** 847-705-7709

**MAIL ADDRESS:**
- **STREET 1:** 616 N. NORTH COURT, SUITE 120
- **STREET 2:** .
- **CITY:** PALATINE
- **STATE:** IL
- **ZIP:** 60067

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** HALSEY DRUG CO INC/NEW
- **DATE OF NAME CHANGE:** 19920703

?xml version="1.0" encoding="utf-8"?

**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**

Date of Report (Date of earliest event reported): **February 2, 2023**

**___________________________________________________________**

**ACURA PHARMACEUTICALS, INC.**

(Exact Name of Registrant as specified in its Charter)

**___________________________________________________________**

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| | | |
|:---|:---|:---|
| **New York** | **1-10113** | **11-0853640** |
| (State or other jurisdiction of | (Commission File Number) | (I.R.S. Employer |
| incorporation or organization) |  | 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)

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **<u>Title of Each Class</u>** | **<u>Trading Symbol(s)</u>** | **<u>Name of Each Exchange on Which Registered</u>** |
| Common Stock, $0.01 par value per share | ACUR | OTC Market – OTC Expert Market  |

---

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:

◻ 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 (17CFR 240.14d-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 8.01 – Other Events** **.** 

Acura Pharmaceuticals, Inc. announces that the first clinical study for its investigational drug LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using Acura's LIMITx technology commenced enrollment. The study, AP-LTX-311 or Study 311, is designed to evaluate the levels of hydrocodone and acetaminophen in the blood plasma when taken at doses in excess of normal therapeutic doses. The LIMITx technology is designed to minimize risks associated with overdose by lowering the maximum drug concentration of hydrocodone in the blood as increasing numbers of tablets are ingested. The Company expects topline results from Study 311 to be available in the second quarter of 2023.

Study 311 is a phase 1 pharmacokinetic study in fasted healthy adult subjects who will be taking 2, 5 and 9 tablet doses. Study 311 is targeted to have 20 subjects complete all doses which will be administered in crossover fashion over a 4 week dosing period, with one week washout between doses. All subjects will receive an intravenous naloxone blockade during drug administration to negate the pharmacologic effects of the opioid hydrocodone. The Company expects to compare the results from the LTX-03 doses to the known, well-characterized pharmacokinetic results for hydrocodone and acetaminophen from the published literature with the intent to demonstrate lower levels of hydrocodone exposure for LTX-03 compared to the currently marketed comparator product as increasing number of tablets are ingested. The acetaminophen active ingredient is not incorporated into the LIMITx technology in the LTX-03 tablet and is not expected to be substantially different from the comparator product.

**LTX-03 (hydrocodone with acetaminophen)**

Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic. Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. Our goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets. In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 34% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription. The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the Food and Drug Administration's (FDA) recently proposed new guidelines for the approval of opioid products.

**Forward-Looking Statements**

Statements in this Current Report 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:

&nbsp;&nbsp;&nbsp;&nbsp;• our ability to fund or obtain funding for our continuing operations, including the development of our
products utilizing our LIMITx and IMPEDE technologies;

&nbsp;&nbsp;&nbsp;&nbsp;• whether we will receive FDA acceptance for an NDA for LTX-03 by the target date;

&nbsp;&nbsp;&nbsp;&nbsp;• whether our licensees will terminate the license prior to commercialization;

&nbsp;&nbsp;&nbsp;&nbsp;• the expected results of clinical studies relating to LTX-03 or any successor product candidate, the date
by which such studies will complete and the results will be available and whether any product candidate will ultimately receive FDA approval;

&nbsp;&nbsp;&nbsp;&nbsp;• the ability of LTX-03 single tablets to achieve bioequivalence or to demonstrate efficacy in a clinical
study;

&nbsp;&nbsp;&nbsp;&nbsp;• whether our licensing partners will develop any additional products and utilize Acura for such development;

&nbsp;&nbsp;&nbsp;&nbsp;• whether LIMITx will retard the release of opioid active ingredients as dose levels increase;

&nbsp;&nbsp;&nbsp;&nbsp;• whether the extent to which products formulated with the LIMITx technology mitigate respiratory depression
risk will be determined sufficient by the FDA;

&nbsp;&nbsp;&nbsp;&nbsp;• our and our licensee's ability to successfully launch and commercialize our products and technologies;

&nbsp;&nbsp;&nbsp;&nbsp;• our and our licensee's ability to obtain necessary regulatory approvals and commercialize products
utilizing our technologies;

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

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

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

&nbsp;&nbsp;&nbsp;&nbsp;• 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;

&nbsp;&nbsp;&nbsp;&nbsp;• the adequacy of the development program for our product candidates, including whether additional clinical
studies will be required to support an NDA and FDA approval of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;• changes in regulatory requirements;

&nbsp;&nbsp;&nbsp;&nbsp;• adverse safety findings relating to our commercialized products or product candidates in development;

&nbsp;&nbsp;&nbsp;&nbsp;• 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 technologies; and

&nbsp;&nbsp;&nbsp;&nbsp;• whether our product candidates will ultimately perform as intended in commercial settings.

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.

 **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.

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| | |
|:---|:---|
| **ACURA PHARMACEUTICALS, INC.** | **ACURA PHARMACEUTICALS, INC.** |
| By: | /s/ Peter A. Clemens |
|  | Peter A. Clemens |
|  | Senior Vice President & Chief Financial Officer |

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Date:&nbsp;&nbsp;&nbsp;&nbsp; February 2, 2023