Just How Bad Is Alkermes' FDA Depression Drug Setback?

TL;DR

Alkermes' depression drug, ALKS 5461, faced a significant setback as an FDA advisory panel voted overwhelmingly against its approval.

Transcript

Shannon Jones: Let’s dig into Alkermes. For our listeners, on November 1st, Alkermes, ticker ALKS, had the opportunity to make its case for its depression drug, ALKS 5461 -- we'll just call it 5461 -- in front of an FDA advisory panel of experts. 5461 has been studied, is still being studied, in treatment-resistant major depressive disorder. But th... Read More

Key Insights

• 🥺 ALKS 5461 faced initial FDA concerns that led to a refuse to file letter but was later clarified by Alkermes.
• 👍 The FDA advisory panel overwhelmingly voted against approving ALKS 5461 due to concerns over efficacy and safety.
• 😒 Alkermes' trial design, which attempted to mitigate the placebo effect, and its use of a novel rating scale were criticized by the FDA.

Questions & Answers

Q: What challenges did ALKS 5461 face during its FDA review?

ALKS 5461 faced initial FDA concerns leading to a refuse to file letter. Despite clarifications, the drug faced criticism during the advisory panel review for lacking substantial evidence of efficacy.

Q: What was unique about the trial design of ALKS 5461?

Alkermes used a sequential parallel comparison design (SPCD) to address the placebo effect. However, the FDA did not find merit in this novel approach, and the trial ultimately failed to prove the drug's effectiveness.

Q: What are the existing treatments for major depression?

Current antidepressant therapies often manipulate serotonin levels in the brain. However, these treatments have limited success, with 60-70% of patients failing to respond and less than 30% achieving remission.

Q: What other products does Alkermes have in its pipeline?

Alkermes has approved products, including Vivitrol for preventing relapses in addiction and Aristada, an atypical antipsychotic. They are also developing a manipulation of Zyprexa for schizophrenia and an early immuno-oncology asset.

Summary & Key Takeaways

• Alkermes' depression drug, ALKS 5461, has had a turbulent history, with an initial refuse to file letter from the FDA and subsequent clarifications.

• The FDA advisory panel voted 21-2 against approving ALKS 5461, with concerns about the drug's efficacy and safety.

• The trial design and use of novel approaches by Alkermes, such as combining an opiate and a counteracting compound, raised further issues.