Novel Partnership Created to Develop Opioid-induced Constipation Drug

Purdue Pharma and Shionogi & Co recently announced the creation of an alliance to launch and commercialize naldemedine (Symproic).

Naldemedine is a peripherally-acting mu opioid receptor antagonist for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, according to a press release from Purdue. The drug is also currently under FDA review with a target action date under the Prescription Drug User Fee Act of March 23, 2017.

Purdue is a pharmaceutical company that has expertise in research, products, and programs regarding pain, and Shionogi is a drug discovery-based pharmaceutical company. This novel alliance joins together Purdue’s prowess in the care of patients experiencing pain with Shionogi’s comprehensive knowledge as the inventor and developer of the drug.

The companies will collaborate to launch and commercialize the drug, which includes extensive collaboration on strategies, sales, and other aspects of the launch, according to the press release.

“Shionogi is very pleased to create this alliance with Purdue, which is well established as the US leader in providing treatments for those burdened with chronic pain,” said Isao Teshirogi, PhD, president and chief executive officer of Shionogi. “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.”

Treatment with opioids may be necessary for pain management after a major surgery, or to treat chronic or acute pain, although the drug’s effects on chronic pain are largely unproven. Due to higher prescription rates, more patients may be experiencing OIC.

Many patients experience constipation as a side effect of treatment with opioids, especially among patients who may be prescribed the drug for a longer period of time.

After the initiation of opioid treatment, OIC is characterized by: reduced bowel movements, development or worsening of straining to pass bowel movements, a sense of incomplete evacuation, or harder stool consistency, Purdue reported in the press release.

Patients may be able to prevent OIC with increased hydration, fiber intake, as well as increasing physical activity. Patients with chronic non-cancer pain may also experience nausea, vomiting, bloating, cramping, heartburn, and loss of appetite due to OIC.

“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,” said Mark Timney, president and chief executive officer of Purdue. “We’ve had a successful, long-term, strategic relationship with Shionogi for two decades and we look forward to continuing our work with them.”