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- A multicenter clinical trial published in JAMA Network Open demonstrates that rapid induction with SUBLOCADE using a single 4 mg oral buprenorphine dose followed by same-day injection improves patient retention compared to standard protocols. - The rapid induction approach was particularly effective among fentanyl-positive participants, addressing a critical need for flexible treatment strategies in the current fentanyl era. - The study showed that administering the second SUBLOCADE injection just one week after the first was well tolerated in both treatment arms, supporting more agile patient-centered treatment models.
- Indivior has discontinued marketing of Opvee, its controversial overdose-reversal medication, following a settlement with New York Attorney General Letitia James after two years of poor sales and intense scrutiny. - The company will refund all public dollars used to purchase Opvee in New York and accept returns of unused units, while also reforming its marketing practices. - Harm reduction advocates had warned that Opvee's ultra-potent active ingredient nalmefene could send overdose victims into severe withdrawal symptoms lasting up to 12 hours, potentially causing unnecessary suffering. - The settlement represents a significant setback for Indivior, which has faced repeated scandals despite developing other effective addiction treatment products like Suboxone and Sublocade.
- A comprehensive pipeline analysis reveals over 5 companies developing novel treatments for Cannabis Use Disorder (CUD), with AEF0117 by Aelis Farma representing a promising new pharmacological class in clinical trials. - The CUD therapeutic landscape includes drugs across multiple development stages from discovery to Phase III, with various routes of administration including oral, intravenous, subcutaneous, parenteral, and topical formulations. - Key players such as Aelis Farma, Anebulo Pharmaceuticals, and Indivior are advancing promising products like AEF0117, ANEB-001, and INDV-5004 through different phases of clinical development. - The pipeline assessment highlights significant collaborative efforts, acquisition activities, and licensing agreements aimed at addressing the critical unmet medical needs in cannabis use disorder treatment.
- Indivior has successfully completed IND-enabling studies for its GABAB positive allosteric modulator (PAM) program in substance use disorders, marking the final preclinical development stage before clinical trials can begin. - The compound was developed through a research collaboration with Addex Therapeutics, which is eligible for up to $330 million in milestone payments plus tiered royalties from high single digits to low double-digit percentages. - GABAB PAMs represent a promising therapeutic approach that may offer improved efficacy with fewer adverse effects compared to existing GABAB receptor agonists like baclofen, which is limited by side effects and tolerance development.
- The pharmaceutical industry has experienced significant leadership changes in early 2025, with major transitions at companies including Pfizer, Boehringer Ingelheim, and Takeda. - Former FDA CDER Director Patricia Cavazzoni's move to Pfizer as Chief Medical Officer has sparked "revolving door" criticisms, highlighting ongoing concerns about regulatory-industry transitions. - Several biotechnology firms have strengthened their executive teams with specialized expertise in clinical development, particularly in areas like stroke treatment, antibody-drug conjugates, and neuropsychiatric therapies.
• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.
• The FDA granted Priority Review to Indivior's sNDA for SUBLOCADE®, setting a PDUFA date of February 7, 2025. • The sNDA seeks approval for alternative injection sites (thigh, buttock, back of the arm) for both induction and maintenance. • The submission includes a rapid induction protocol, reducing induction time to one hour after a single transmucosal buprenorphine dose. • If approved, these label updates would significantly enhance patient experience and expand treatment access for opioid use disorder.
• Aelis Farma's AEF0117 did not meet its primary endpoint of reducing cannabis use to one day or less per week in patients with moderate to severe cannabis use disorder (CUD). • The Phase 2B trial also failed to meet secondary endpoints, including complete cessation of marijuana use or reduction to two days or less per week. • Indivior, which had an option to license AEF0117, announced it does not currently expect to exercise this option due to the lack of separation from placebo in the trial. • AEF0117 was well-tolerated, with adverse events similar across treatment groups, including placebo, indicating no significant safety concerns.
