Axsome Advances MDD Drug, Explores New ADHD Treatment

 Three months after striking a deal to acquire the excessive daytime sleepiness drug Sunosi from Jazz Pharmaceuticals, Axsome Therapeutics is planning to assess the dual-acting dopamine and norepinephrine reuptake inhibitor in a Phase III attention deficit hyperactivity disorder (ADHD) study.

On Tuesday, Axsome hosted an investor day event to provide an update on plans for Sunosi following the $53 million deal that brought it into the company's portfolio. Additionally, Axsome provided updates on other developmental assets, including major depressive disorder (MDD) treatment AXS-05 (dextromethorphan-bupropion), which is under review by the U.S. Food and Drug Administration. 

In a Monday filing with the U.S. Securities and Exchange Commission, Axsome announced that the FDA provided the company with proposed labeling for AXS-05 related to a New Drug Application filing. Axsome said it was reviewing the proposed labeling and is expected to reply to the FDA to secure a final agreement. 

AXS-05 is an NMDA receptor antagonist that uses a proprietary formulation and dose of dextromethorphan and bupropion. Earlier this month, the company presented new data from the Phase III GEMINI study on MDD that showed AXS-05 provided "substantial and statistically significant improvement in depressive symptoms and induction of remission."

That notification from the FDA is significantly good news for Axsome since it had hoped that AXS-05 would already have a year's worth of approval. The company expected potential approval in 2021, but the FDA announced that its review of the data would not be completed by the time the initial PDUFA date had been set. 

In its year-end financial report in March, Axsome said it has answered all CMC questions the regulatory agency raised about that delay. AXS-05 is under Priority Review.

For Sunosi, the company outlined its vision to achieve approval for a supplemental New Drug Application in ADHD, a common, chronic neurodevelopmental disorder. During the investor event, Stephen V. Faraone, a professor in the departments of psychiatry and neuroscience and physiology at SUNY Upstate Medical University, explained that throughout the lifetime of a patient, ADHD increases the risk of multiple psychiatric disorders, including depression and suicide, as well as occupational failure and addiction. 

While there are several medications approved for ADHD, there are problems with many of them, including concerns over non-adherence and the fact that some of the drugs are stimulants that can be misused and abused. Axsome believes that Sunosi can play a unique role in treating ADHD and meeting some of the unmet needs of that patient population. 

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor. Amanda Jones, senior vice president of clinical development at Axsome, noted that both dopamine and norepinephrine are implicated in the pathophysiology of ADHD. She also explained that as a non-stimulant, Sunosi has a low potential for abuse. The company plans to conduct a four-week Phase III study in this indication to assess its potential. 

Additionally, the company intends to conduct a study assessing if Sunosi can improve cognitive outcome measures in patients with excessive daytime sleepiness associated with obstructive sleep apnea (OSA). About 40% of OSA patients complain of cognitive difficulties. 

Data from both of these Sunosi studies are expected later this year. Axsome believes that Sunosi has significant upside in additional indications and intends to explore those options to maximize returns on its investment.

https://www.biospace.com/article/axsome-explores-new-indications-for-sunosi-sees-light-at-the-end-of-the-tunnel-for-experimental-mdd-drug/