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On Track To Approval, Alkermes Hopes ALKS-5461 Can Change Future Of Depression Therapy

 
• By Joseph Haas

The novel opioid-system antidepressant is being positioned for adjunctive therapy on top of SSRIs, but Alkermes is eyeing other indications, and better ways to stratify and treat depressed patients.

magnetic resonance image (MRI) of the brain human

Looking ahead to possible US FDA approval of ALKS-5461 early next year, Alkermes PLC CEO Richard Pops hopes the product will lead to the evaluation of depression drug candidates via newer endpoints and bring the treatment of depression closer to precision medicine.

ALKS-5461 is a fixed-dose combination of the partial mu-opioid receptor agonist and kappa-opioid receptor antagonist buprenorphine with the mu-opioid receptor...

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More from Neurological

Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 
• By Andrew McConaghie

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Sumitomo Parkinson’s Filing A Pivotal Moment For Japan’s iPSC Ambitions

 
• By Lisa Takagi

Sumitomo Pharma's iPSC therapy for Parkinson's has been filed for approval in Japan after showing safety and efficacy in a Phase I/II trial and may become one of the first such therapies to reach the market in the country, which has invested heavily in the modality.

Vertex’s Pain Drug Failure Adds To Investor Doubts

 
• By Andrew McConaghie

A Phase II trial to develop a second NaV1.8 pain signal inhibitor for acute pain has failed and the US FDA has given a thumbs down on Journavx’s path to broader use in peripheral neuropathic pain.

AbbVie Raises Full-Year Sales Guidance On Skyrizi/Rinvoq Strength

 
• By Joseph Haas

AbbVie now expects the two Humira successors to bring in $25bn this year. On its Q2 earnings call, the firm also pointed to strength in neuroscience, with 24% growth.

More from Therapy Areas

Boehringer Scores First Approval For Targeted Oral Drug In HER2-Mutant NSCLC

 
• By Alaric DeArment

The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.

Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 
• By Alexandra Shimmings

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.