The FDA approved solriamfetol (Sunosi, Jazz Pharmaceuticals) on 3/20/2019 to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
The FDA approved brexanolone (Zulresso, Sage Therapeutics)on 3/19/2019 for the treatment of postpartum depression.
The FDA granted Qualified Infectious Disease Product (QIDP)to the oral and IV formulations of sulopenem in March 2019.
The FDA rejected sotagliflozin on 3/22/2019.Lexicon and Sanofi are working with the FDA to determine future development of the drug.
Spectrum withdrew the BLA for eflapegrastimto provide more information to the FDA on the chemistry, manufacturing and controls process.
Two Trials Published
In a draft cost-effectiveness analysis, ICER estimated a quality-adjusted life year of $826,000 for use of siponimod in the treatment of secondary progressive multiple sclerosis, assuming the same cost for siponimod as ocrelizumab.
In a 48-hour, 389 patient, Phase III trial, 50% of Trevena’s oliceridine 0.1 mg patients, 62% of 0.35 mg patients and 65.8% of 0.5 mg patients reached the combination endpoint of a 30% or > improvement in pain (SPID-48), received no rescue drugs, completed the study period and did not reach dosing limits compared to with 15.2% that received placebo in patients with moderate-to-severe pain following bunionectomy. The 0.35 mg and 0.5 mg doses were non-inferior to morphine in reaching the primary endpoint. In a 389 patient, Phase III trial, GI ADR increased in a dose-dependent manner in oliceridine regimens; 40.8% with 0.1 mg, 59.5% with 0.35 mg and 70.9% with 0.5 mg compared to 24.1% with placebo and 72.4% with morphine.
Five Announced Investigational Drug Developments
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