Sage Therapeutics (NASDAQ:SAGE) is up 8% premarket on light volume in response to its announcement that it believes it will be able to file a New Drug Application (NDA) with the FDA sometime in 2018 seeking approval of lead product candidate SAGE-547 for the treatment of postpartum depression.
The company is basing its expedited development plan on the formal minutes from its breakthrough therapy meeting with the agency. It says prior Phase 2 data along with results from two current studies (202B and 202C) should be sufficient to support the filing. The clinical program will require only minor modifications, including an increase in sample size. The efficacy endpoints have been agreed upon.
Top-line data from the registration trials should be available in H2 2017.
SAGE-547 is an allosteric modulator of both synaptic (junction between nerve cells) and extra-synaptic GABAa receptors. When activated, GABAa receptors cause the neuron to hyperpolarize which inhibits neurotransmission. It is also under development for the treatment of super-refractory status epilepticus.
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