The FDA approves Evoke Pharma’s (EVOK +2.6%) Gimoti (metoclopramide) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis, a disorder in which the stomach’s contractions are disrupted compromising digestion.
The company says the nod allows it to access its $5M credit line to support manufacturing and other aspects of commercialization.
The application was its second try. It received a CRL in April 2019 citing the need for additional data related to clinical pharmacology and product quality/device quality.
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