Symproic Approved for Treating Opioid-Induced Constipation
March 23, 2017 – The U.S. FDA approved Symproic® (naldemedine), manufactured by Shionogi and Purdue Pharma. Symproic is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Since the drug is structurally related to naltrexone, it is currently considered a schedule CII narcotic. The recommended dose is one 0.2mg tablet taken once daily with or without food. The companies expect to launch Symproic by mid-summer.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.