March 26 Quick Takes: Pear’s digital therapeutic approved for insomnia; plus Medimetriks-Otsuka, Merck KGaA, Jazz, Roche, EpiVax
FDA approves Pear’s cognitive behavioral insomnia therapy
FDA approved Somryst from Pear Therapeutics Inc. to treat chronic insomnia. The prescription digital therapeutic is the first to be approved via simultaneous review under the standard 510(k) pathway and the agency’s software precertification pilot program. The 9-week cognitive behavioral therapy includes algorithm-driven sleep restriction and consolidation recommendations and can be used on smartphones and other mobile devices.
Medimetriks planning U.S. Phase III in atopic dermatitis
Medimetriks Pharmaceuticals Inc. is preparing for Phase III testing of difamilast (MM36) in the U.S. after reporting top-line results from two Phase III Japan trials conducted by Otsuka Pharmaceutical Co. Ltd. in adult and pediatric atopic dermatitis patients. The PDE-4 inhibitor decreased the severity of systemic symptoms compared with vehicle. Medimetriks has U.S. rights to difamilast from Otsuka. ...