Baclofen

Addex and Indivior Extend Research Term of Substance Use Disorder GABAB Positive Allosteric Modulator Discovery Collaboration

Retrieved on: 
Thursday, December 8, 2022

As part of the amended agreement, Indivior will pay Addex an additional USD 1 million to cover additional research activities during this extended period.

Key Points: 
  • As part of the amended agreement, Indivior will pay Addex an additional USD 1 million to cover additional research activities during this extended period.
  • Addex retains exclusive rights to develop its own independent GABAB PAM program and is advancing compounds in Charcot-Marie-Tooth type 1A neuropathy (CMT1A), chronic cough and pain.
  • Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention.
  • Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates, with a focus on substance use disorder.

Alcohol Use Disorder Market to Witness Positive Growth at a CAGR of 8.8% by 2032 | DelveInsight

Retrieved on: 
Wednesday, September 28, 2022

LAS VEGAS, Sept. 28, 2022 /PRNewswire/ --DelveInsight's Alcohol Use Disorder Market Insights report includes a comprehensive understanding of current treatment practices, alcohol use disorder emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), Japan].

Key Points: 
  • Leading alcohol use disordercompanies such as Alkermes, Lundbeck, Otsuka Pharmaceuticals, Adial Pharmaceuticals, MediciNova, Corcept Therapeutics, Astellas Pharma, Bioprojet, and others are developing novel alcohol use disorder drugs that can be available in the alcohol use disorder market in the upcoming years.
  • DelveInsight estimates that there were approximately 25 million 12-month diagnosed prevalent cases of alcohol use disorder in the 7MM in 2021.
  • TOPAMAX (topiramate) is even recommended for alcohol use disorder treatment by the National Institute on Alcohol Abuse and Alcoholism.
  • Moreover, because of the change in alcohol use disorder diagnostic criteria from DSM-IV to DSM-V, country-specific epidemiologic data on diagnosis, severity, and treatment are scarce and thus limiting the alcohol use disorder market growth.

Pharnext Announces First Patient Enrolled in Open Label Extension of the Pivotal Phase III Study of PXT3003 for the Treatment of Charcot-Marie-Tooth Disease Type 1A, the PREMIER Trial

Retrieved on: 
Monday, September 12, 2022

Pharnext Announces First Patient Enrolled in Open Label Extension of the Pivotal Phase III Study of PXT3003 for the Treatment of Charcot-Marie-Tooth Disease Type 1A, the PREMIER Trial

Key Points: 
  • Pharnext Announces First Patient Enrolled in Open Label Extension of the Pivotal Phase III Study of PXT3003 for the Treatment of Charcot-Marie-Tooth Disease Type 1A, the PREMIER Trial
    Dissemination of a French Regulatory News, transmitted by EQS Group.
  • The dose of PXT3003 tested in the PREMIER trial corresponds to the HD tested in the prior Phase III clinical study, the PLEO-CMT trial, and the ongoing open-label extension Phase III study, the PLEOCMT-FU trial.
  • The dose of PXT3003 tested in the PREMIER trial corresponds to the high dose (HD) tested in the prior Phase III trial (PLEO-CMT).
  • An international pivotal Phase III study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing.

Addex and Indivior Extend GABAB Positive Allosteric Modulator Research Collaboration for Substance Use Disorders

Retrieved on: 
Monday, August 15, 2022

As part of the amended agreement, Indivior will provide Addex with CHF 850,000 (approx.

Key Points: 
  • As part of the amended agreement, Indivior will provide Addex with CHF 850,000 (approx.
  • Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention.
  • Addex's second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in a range of indications.
  • Indivior PLC has licensed Addexs GABAB PAM program for the development of drug candidates, with a focus on substance use disorder.

Pharnext Announces On-Schedule Completion of Patient Enrollment in its Pivotal Phase III Trial of PXT3003, the PREMIER Trial, for the Treatment of Charcot-Marie-Tooth Disease Type 1A

Retrieved on: 
Monday, May 30, 2022

Pharnext Announces On-Schedule Completion of Patient Enrollment in its Pivotal Phase III Trial of PXT3003, the PREMIER Trial, for the Treatment of Charcot-Marie-Tooth Disease Type 1A

Key Points: 
  • Pharnext Announces On-Schedule Completion of Patient Enrollment in its Pivotal Phase III Trial of PXT3003, the PREMIER Trial, for the Treatment of Charcot-Marie-Tooth Disease Type 1A
    Dissemination of a French Regulatory News, transmitted by EQS Group.
  • The dose of PXT3003 tested in the PREMIER trial corresponds to the high dose (HD) tested in the prior Phase III clinical study, the PLEO-CMT trial, and the ongoing open-label extension Phase III study, the PLEOCMT-FU trial.
  • For more information on the PREMIER trial please refer to the About the PREMIER Trial paragraph below.
  • The dose of PXT3003 tested in the PREMIER trial corresponds to the high dose (HD) tested in the prior Phase III trial (PLEO-CMT).

New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time

Retrieved on: 
Monday, May 16, 2022

The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.

Key Points: 
  • The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.
  • All randomized CMT1A patients who completed the PLEO-CMT trial (treated with PXT3003 or placebo) were eligible to pursue treatment with PXT3003 in the PLEO-CMT-FU trial.
  • This trial enrolled a total of 187 patients and was designed to primarily assess the long-term safety and tolerability of PXT3003.
  • Patients treated with placebo in the PLEO-CMT trial were randomized in PLEO-CMT-FU to receive LD or HD of PXT3003.

New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time

Retrieved on: 
Monday, May 16, 2022

The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.

Key Points: 
  • The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.
  • All randomized CMT1A patients who completed the PLEO-CMT trial (treated with PXT3003 or placebo) were eligible to pursue treatment with PXT3003 in the PLEO-CMT-FU trial.
  • This trial enrolled a total of 187 patients and was designed to primarily assess the long-term safety and tolerability of PXT3003.
  • Patients treated with placebo in the PLEO-CMT trial were randomized in PLEO-CMT-FU to receive LD or HD of PXT3003.

Amneal Expands Injectables Portfolio with 4 New Products

Retrieved on: 
Thursday, February 17, 2022

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced the approval of four generic injectables products.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced the approval of four generic injectables products.
  • An important element of Amneals long-term growth strategy is expanding our injectables business, and todays announcement of four new approvals is another key step.
  • The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars.
  • In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs.

Texas Original Compassionate Cultivation Opens Pick-Up Location in El Paso, Texas

Retrieved on: 
Tuesday, February 8, 2022

Texas Original Compassionate Cultivation (TXOG), Texas leading medical cannabis provider, announced the opening of its newest prescription pick-up location in El Paso, Texas, for patients who qualify under the Compassionate Use Program (CUP).

Key Points: 
  • Texas Original Compassionate Cultivation (TXOG), Texas leading medical cannabis provider, announced the opening of its newest prescription pick-up location in El Paso, Texas, for patients who qualify under the Compassionate Use Program (CUP).
  • The announcement follows the companys recent expansion of its distribution services for patients in El Paso, the Texas Panhandle, the Rio Grande Valley and Northeast Texas.
  • The opening of our El Paso pick-up location is the latest example of how Texas Original is expanding our footprint to build awareness of the Compassionate Use Program and drive patient growth throughout the state of Texas, said Morris Denton, CEO of TXOG.
  • Texas Original Compassionate Cultivation (TXOG) is the leading licensed medical marijuana producer in Texas, working alongside physicians to provide the highest quality cannabis medicine to patients and families seeking relief across the state.

AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF FLEQSUVY™ (baclofen oral suspension)

Retrieved on: 
Monday, February 7, 2022

"The approval of FLEQSUVY represents our commitment to providing innovative alternative formulations that address individualized patient needs.

Key Points: 
  • "The approval of FLEQSUVY represents our commitment to providing innovative alternative formulations that address individualized patient needs.
  • As the most concentrated FDA-approved oral liquid baclofen formulation, FLEQSUVY allows for the lowest volume to be prescribed for patients,5,6 which can be an important consideration for those suffering from dysphagia.
  • FLEQSUVYis a grape-flavored oral suspension formulation of baclofen approved by the FDA for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
  • Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of patients with underserved conditions.