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Shionogi, Purdue partner to commercialize Symproic in U.S.
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Shionogi and Purdue Pharma have partnered to launch and commercialize naldemedine as Symproic in the U.S., according to a press release.
Naldemedine is a peripherally-acting mu opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. It is currently under review by the FDA following safety and efficacy data reported from the COMPOSE trials, with a Prescription Drug User Fee Act (PDUFA) target action date of Mar. 23, 2017.
“Shionogi is very pleased to create this alliance with Purdue, which is well established as the U.S. leader in providing treatments for those burdened with chronic pain,” Isao Teshirogi, PhD, president and CEO of Shionogi, said in the press release. “We firmly believe that Purdue is optimally positioned to bring naldemedine to market, following approval by FDA for the treatment of OIC in adult patients with chronic non-cancer pain, to benefit the appropriate patients and to the healthcare providers that care for them.”
The companies will jointly launch and commercialize the product with a comprehensive collaboration in sales, strategy and other activities, according to the press release.
“This alliance brings us into an exciting new therapeutic area and offers us the opportunity to further help patients with chronic pain while advancing our plans to diversify in high need areas adjacent to pain,” Mark Timney, president and CEO of Purdue, said in the press release. “We’ve had a successful, long-term, strategic relationship with Shionogi for two decades and we look forward to continuing our work with them.”
Disclosures: Teshirogi is employed by Shionogi. Timney is employed by Purdue.