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Alkermes Submits NDA to FDA for Schizophrenia & Bipolar I Drug

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Alkermes plc. (ALKS - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder. 

Shares of the company have declined 32.4% against the industry’s growth of 4.3%.

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 includes 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 - Free Report) Zyprexa (olanzapine).

Alkermes is seeking approval of fixed dosage strengths of ALKS 3831 composed of 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg or 20 mg of Zyprexa.

We remind investors that in July, after a pre-NDA meeting with the FDA, the company announced its plans to expand the NDA for the candidate to include the treatment of bipolar I disorder in addition to that for schizophrenia.

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

The company has several candidates in its pipeline. Its progress with pipeline candidates targeting major central nervous system (CNS) disorders, such as schizophrenia, addiction, depression and multiple sclerosis, has been impressive

Other players in the schizophrenia treatment market include AstraZeneca plc's (AZN - Free Report) Seroquel XR, Johnson & Johnson's Risperdal Consta and Allergan’s 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 #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.


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