FDA Delays Salix's sNDA On Relistor
By Cyndi Root
The Food and Drug Administration (FDA) delayed Salix Pharmaceutical’s Supplemental New Drug Application (sNDA) for Relistor. Salix bought the rights to Relistor in 2011 and the FDA issued a complete response letter on the sNDA in 2012. The Anesthetic and Analgesic Drug Products Advisory Committee of the FDA was to meet on the request of Salix. The meeting on March 10-11 was postponed by the FDA due to scheduling conflicts. Relistor is indicated for opioid-induced constipation (OIC).
Opioid-induced Constipation (OIC)
People who take opioids often experience constipation. The exact cause of OIC is unknown, but several possible causes include the anal sphincter losing tone, the small intestine and colon suffering deficits in peristalsis, or movement of the bowels. Some patients respond to taking laxatives, but others with advanced illness need other options. Constipation can cause an uncomfortable feeling, pain in the stomach, vomiting, and sometimes impaired defecation response (the stool is too large or too hard to release). Some patients that suffer from these effects stop taking their pain medication to get relief from the constipation, but medication stoppage negatively impacts successful recovery from their disease or condition.
Relistor
Relistor is a subcutaneous injection for patients who have not responded to laxatives. Patients usually take one dose every other day, and no more than once per day. Doses range from 8 mg to 12 mg. The injection comes in a sterile bottle with a clear or light yellow solution. Injection sites include the thigh, abdomen, and the upper arm. Patients should rotate injection sites. Some patients who have taken Relistor have reported gastrointestinal perforations in the colon, stomach, or duodenum. Patients with previously diagnosed lesions should not take the drug. Some patients have reported severe diarrhea using the drug.
About Salix
Salix is an American specialty pharmaceutical company. It develops, licenses, and markets drugs for gastrointestinal diseases. One of the company’s strategies is to search for and acquire late stage drugs that have documented efficacy. Salix promotes its products with an in-house sales force that builds relationships with the gastroenterology community. The company believes in the strength of the U.S. market and concentrates on sales in the U.S. while building alliances for marketing globally.