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Alkermes to Include Bipolar I Disorder in ALKS 3831 NDA

Zacks Equity Research

Alkermes Plc. ALKS announced that after a pre-new drug application (NDA) meeting with the FDA, it plans to expand the NDA for ALKS 3831 to include the treatment of bipolar I disorder in addition to the treatment for schizophrenia. Shares of the company were up 3.6% following the news.

Shares of Alkermes have declined 20.9% year to date compared with the industry’s decline of 0.2%.

Schizophrenia is a chronic, severe and disabling brain disorder. Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. The NDA for ALKS 3831, which is to be submitted in the fourth quarter of 2019, will include data from the completed ENLIGHTEN clinical development program in patients with schizophrenia and pharmacokinetic (PK) bridging data comparing ALKS 3831 with Eli Lilly & Co.’s LLY Zyprexa (olanzapine).

The ALKS 3831 NDA will include data to support the treatment of manic or mixed episodes associated with bipolar I disorder as a monotherapy, or adjunct to lithium or valproate, and the maintenance treatment of bipolar I disorder. It will include additional data to support the treatment of schizophrenia.

Approval of the additional indication will help Alkermes gain access to a broader section of patients.

Other players in the schizophrenia treatment market include AstraZeneca plc's AZN Seroquel XR, Johnson & Johnson's Risperdal Consta and Allergan’s AGN Vraylar. Vraylar is also approved for the treatment of adults with major depressive episodes related to bipolar I disorder.

Alkermes currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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