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USFDA accepts review application from Valeant Pharmaceuticals International and Progenics Pharmaceuticals

USFDA accepts review application from Valeant Pharmaceuticals International and Progenics Pharmaceuticals

USFDA has in principal given nod for the tablets-based treatment of opioid-induced constipation by accepting RELISTOR (methylnaltrexone bromide) Tablets

Valeant Pharmaceuticals International, Inc. and Progenics Pharmaceuticals, Inc. have recently reported in the media that the U.S. Food and Drug Administration (FDA) has given its nod to review a drug RELISTOR for the treatment of  opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

The application for the (methylnaltrexone bromide) Tablets has been filed by the Valeant’s, and the company further confirmed that FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 19, 2016. Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant Pharmaceuticals.

RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.

Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia. Take into account the overall risk-benefit profile when using RELISTOR in such patients. Monitor for adequacy of analgesia and symptoms of opioid withdrawal in such patients.

In the clinical study in adult patients with opioid-induced constipation and chronic non-cancer pain, the most common adverse reactions (≥ 1%) were abdominal pain, nausea, diarrhea, and hyperhidrosis, hot flush, tremor, and chills.

In clinical studies in adult patients with opioid-induced constipation and advanced illness, the most common adverse reactions (≥ 5%) were abdominal pain, flatulence, nausea, dizziness, and diarrhea.

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