FDA approves Symproic (naldemedine) to treat opioid-induced constipation.- Shionogi + Purdue Pharma

Shionogi Inc. and Purdue Pharma L.P. announced that the FDA approved Symproic (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Shionogi Inc. submitted a petition for the descheduling of Symproic, or removal of the controlled substance classification, to the U.S. Drug Enforcement Administration (DEA), which is currently under evaluation.

Symproic will be jointly launched and commercialized in the U.S. with Purdue Pharma and is expected to be commercially available mid-summer. The FDA approval of Symproic was based on data from the COMPOSE program, a global comprehensive development program comprised of clinical studies conducted in adult patients with OIC and chronic non-cancer pain. It was comprised of three studies: COMPOSE I, COMPOSE II and COMPOSE III. COMPOSE I and II were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, while COMPOSE III was a 52-week, randomized, double-blind, placebo-controlled, long-term safety study.

Comment: Competitors are Movantik (naloxegol) from AstraZeneca + Daiichi Sankyo + Kyowa Hakko, and Amitiza (lubiprostone) from Sucampo + Takeda and Relistor (methylnatrexone bromide) from Salix/Valeant .