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FDA accepts investigational drug application for schizophrenia treatment
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The FDA has accepted an investigational drug application for MIN-101, a 5-HT2a and sigma2 antagonist from Minerva Neurosciences, for treatment of schizophrenia, according to a company press release.
A randomized, placebo-controlled, double-blind European phase 2b trial of MIN-101 will be conducted among 244 individuals.
Remy Luthringer
The trial will assess efficacy of the drug to treat negative symptoms of schizophrenia, including cognitive symptoms and overall symptomatology.
Results from the 12-week treatment are expected in the second quarter of 2016.
“Acceptance of the [investigational drug application]for MIN-101 is an important step toward the initiation of advanced-stage clinical testing of this compound in the United States following the results of our ongoing phase 2b trial in Europe,” Remy Luthringer, PhD, president and CEO of Minerva, said in a press release. “We will be continuing our dialogue with the FDA as part of our overall planning for late-stage clinical testing in the United States.”