Evoke Pharma, Inc. submitted an application to the U.S. Food and Drug Administration for its nasal spray Gimoti to treat a gastrointestinal disorder.
The Solana Beach, Calif.-based company is seeking approval for Gimoti to provide relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
Diabetic gastroparesis is characterized by episodes of nausea, vomiting, abdominal pain and bloating associated with delayed emptying of the stomach's contents after meals.
The company said women represent an estimated 80% of all patients with the disease and an oral drug may be ineffective in face of a sudden flare of the disorder.
Evoke expects to receive an FDA notification regarding the acceptance of the application for review in early August.
The company acquired the drug from Questcor Pharmaceuticals Inc., which was later bought by Mallinckrodt PLC for $5.6 billion in August 2014.
Mallinckrodt is now eligible to receive estimated future milestone payments of about $51.5 million following the approval of Gimoti.
