Acura Pharmaceuticals

Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03

Retrieved on: 
Tuesday, March 1, 2022

PALATINE, Ill., March 01, 2022 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharmaceuticals, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to December 31, 2022.

Key Points: 
  • PALATINE, Ill., March 01, 2022 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharmaceuticals, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to December 31, 2022.
  • The Company expects to complete clinical studies and other required steps to file the NDA and gain regulatory acceptance by that date.
  • Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose.
  • LIMITx is useful with products whose side effect risks can be mitigated by limiting exposure to a drug in overdose situations.

Acura Pharmaceuticals Provides Development Update on LTX-03

Retrieved on: 
Monday, February 14, 2022

The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale.

Key Points: 
  • The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale.
  • Acura has completed its review of the Advice Letter received in October 2021 from the Food and Drug Administration (FDA) regarding our proposed clinical study program for LTX-03.
  • These protocols have been provided to our development and commercialization partner, Abuse Deterrent Pharmaceuticals, LLC (AD Pharma) for comment and determination of the timing of initiation of the studies.
  • Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse.

Opioid Receptor Agonists Pipeline Research Report 2022: Insights on 40+ Companies and 40+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 3, 2022

This "Opioid Receptor Agonists - Pipeline Insight, 2022" report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Opioid Receptor Agonists pipeline landscape.

Key Points: 
  • This "Opioid Receptor Agonists - Pipeline Insight, 2022" report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Opioid Receptor Agonists pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Opioid Receptor Agonists R&D.
  • This segment of the Opioid Receptor Agonists report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • This segment of the report provides insights about the different Opioid Receptor Agonists drugs segregated based on following parameters that define the scope of the report.

Acura Pharmaceuticals Announces Third Quarter 2021 Financial Results

Retrieved on: 
Monday, November 15, 2021

PALATINE, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR), an innovative drug delivery company engaged in the research, development and commercialization of technologies and products intended to address safe use of medications, announced today financial results for the three and nine months ended September 30, 2021.

Key Points: 
  • PALATINE, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR), an innovative drug delivery company engaged in the research, development and commercialization of technologies and products intended to address safe use of medications, announced today financial results for the three and nine months ended September 30, 2021.
  • The Company also recorded royalty revenue of $67 thousand and $14 thousand, respectively, for the third quarter 2021 and 2020.
  • Research and development expense was $385 thousand for the third quarter 2021, compared to $519 thousand for the same period in 2020.
  • This amount will be reflected in our 4th quarter and full year 2021 results.

Acura Pharmaceuticals Announces Second Quarter 2021 Financial Results

Retrieved on: 
Monday, August 16, 2021

Revenue for the second quarter 2021 and 2020 included $600 thousand and $1.05 million, respectively, in license fees derived from the license agreement with Abuse Deterrent Pharma, LLC (AD Pharma) that was amended in July 2021.

Key Points: 
  • Revenue for the second quarter 2021 and 2020 included $600 thousand and $1.05 million, respectively, in license fees derived from the license agreement with Abuse Deterrent Pharma, LLC (AD Pharma) that was amended in July 2021.
  • The Company also recorded royalty revenue of $3 thousand and $34 thousand, respectively, for the second quarter 2021 and 2020.
  • Research and development expense was $390 thousand for the second quarter 2021, compared to $445 thousand for the same period in 2020.
  • General and administrative expense was $523 thousand for the second quarter 2021, versus $548 thousand for the same period in 2020.

Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03

Retrieved on: 
Monday, July 26, 2021

PALATINE, Ill., July 26, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharma, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to February 28, 2022.

Key Points: 
  • PALATINE, Ill., July 26, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharma, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to February 28, 2022.
  • Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested.
  • Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse.
  • LIMITx is useful with products whose side effect risks can be mitigated by limiting exposure to a drug in overdose situations.

Acura Pharmaceuticals Announces Conversion of Debt

Retrieved on: 
Monday, June 14, 2021

Effective with this conversion, the Note is retired and the Company is working with AD Pharma to release their security interest in all the Companys assets.

Key Points: 
  • Effective with this conversion, the Note is retired and the Company is working with AD Pharma to release their security interest in all the Companys assets.
  • AD Pharma and the Companys minority shareholders are now aligned with respect to the future results of Acura.
  • Acura Pharmaceuticals is an innovative drug delivery company engaged in the research, development and commercialization of technologies and products intended to address safe use of medications.
  • We discuss many of these risks in greater detail in our filings with theSecurities and Exchange Commission.

Acura Pharmaceuticals Provides Development Update on LTX-03

Retrieved on: 
Monday, June 7, 2021

PALATINE, Ill., June 07, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced the successful completion of three NDA required registration batches of the to-be-marketed LTX-03 formulation.

Key Points: 
  • PALATINE, Ill., June 07, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced the successful completion of three NDA required registration batches of the to-be-marketed LTX-03 formulation.
  • We, along with our Partner, Abuse Deterrent Pharmaceuticals, LLC, intend to conduct 3 clinical studies as was proposed to the FDA in our updated IND submitted in February 2021.
  • Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose.
  • Acura Pharmaceuticals is an innovative drug delivery company engaged in the research, development and commercialization of technologies and products intended to address safe use of medications.

Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03

Retrieved on: 
Wednesday, October 28, 2020

PALATINE, Ill., Oct. 28, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharmaceuticals, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date), expand the product licenses, and revise the license payment schedule.

Key Points: 
  • PALATINE, Ill., Oct. 28, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharmaceuticals, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date), expand the product licenses, and revise the license payment schedule.
  • Acuras LIMITx technology, when applied to any pharmaceutical product, is designed to mitigate the adverse consequences associated with the overdose of tablets.
  • The amended Agreement extends the NDA Acceptance Date to July 31, 2021, expands AD Pharmas license to the LIMITx patents to LTX-02 (oxycodone/acetaminophen) and LTX-09 (alprazolam), and revises the license payments, effective as of May 2020, to $200,000 monthly running through July 2021.
  • Development of LTX-02 and/or LTX-09 by Acura on behalf of AD Pharma will be subject to future development agreements, if any.

Acura Pharmaceuticals Announces First Quarter 2020 Financial Results

Retrieved on: 
Monday, June 29, 2020

PALATINE, Ill., June 29, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR), a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse, announced today financial results for the three months ended March 31, 2020.

Key Points: 
  • PALATINE, Ill., June 29, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR), a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse, announced today financial results for the three months ended March 31, 2020.
  • Included in expenses for the first quarter 2020 was a one-time charge of $668 thousand to recognize an impairment in our Aversion intangible asset.
  • Revenue for the three month period ended March 31, 2020 included $1.05 million in license fees derived from the license agreement with Abuse Deterrent Pharma.
  • The Company also recorded royalty revenue of $33 thousand and $67 thousand, respectively, for the three month periods ended March 31, 2020 and 2019.