BioDelivery Sciences Secures Exclusive U.S. Rights to Shionogi’s Symproic for Opioid-Induced Constipation

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on April 10, U.S. local time, BioDelivery Sciences International, a biopharmaceutical company headquartered in Raleigh, North Carolina, obtained an exclusive license for the prescription drug Symproic (naldemedine) from the Japanese pharmaceutical company Shionogi. Under the terms of the deal, BioDelivery Sciences International will pay Shionogi $20 million in upfront cash, an additional $10 million within six months, and quarterly royalties.

Symproic is an oral tablet that was approved by the FDA this March for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The drug primarily exerts its therapeutic effect as a μ-opioid receptor antagonist, helping to alleviate medication-related side effects in patients receiving mild opioid therapy.

A survey found that among 322 patients taking daily opioid therapy for chronic pain, 40% to 50% suffered from constipation, and 33% of these patients attempted to alleviate constipation by reducing or discontinuing their opioid medication.

Constipation is the most common side effect of opioid use. When opioids bind to opioid receptors in the gastrointestinal tract, they reduce intestinal motility, leading to constipation. If patients experience decreased bowel movement frequency, increased difficulty in defecation, a sensation of incomplete rectal evacuation, or hardened stools after taking opioids, these are indicative of opioid-induced constipation (OIC).

However, Symproic is not suitable for patients with intestinal diseases, as these patients may experience severe gastrointestinal perforation after taking the drug. Additionally, pregnant women should use Symproic with caution, because taking this medication may cause opioid withdrawal symptoms in unborn babies, such as sweating, chills, tearing, facial flushing, fever, cold-like symptoms, abdominal pain, diarrhea, nausea, and vomiting.

Dr. Isao Teshirogi, CEO of Shionogi, stated, “The licensing of Symproic is part of our ongoing strategy to strengthen our commercial focus in specialized therapeutic areas. After carefully considering the robust commercial capabilities of BioDelivery Sciences International, Inc., we believe they are our optimal partner to maximize the value of Symproic and help alleviate constipation symptoms in patients with chronic non-cancer pain who are taking opioid medications.”

Shionogi, established on March 17, 1878, is a biopharmaceutical company headquartered in Osaka, Japan. The company is primarily engaged in the research, development, procurement, manufacturing, and sales of pharmaceutical products. Shionogi currently offers therapeutic agents across multiple fields, including infectious diseases, pain, cardiovascular diseases, central nervous system disorders, gastrointestinal diseases, and oncology.

BioDelivery Sciences International, Inc., founded in 1997, is a specialty pharmaceutical company focused on pain management and addiction medicine. The company leverages its proprietary BioErodible MucoAdhesive (BEMA) technology to develop products addressing conditions such as chronic pain, breakthrough cancer pain, and opioid dependence.

(Compiled by Wang Chan)