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Salix And Progenics Announce FDA Extension Of Relistor® sNDA Goal Date To July 27, 2012

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RALEIGH, NC, April 25, 2012 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today announced that the Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s review of the Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The FDA has notified Salix that it requires additional time for a full review of the submission and has extended the April 27, 2012 goal date by the standard extension period of three months. The extended user fee goal date is July 27, 2012. The extension requested no additional studies.

RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. The FDA approved RELISTOR Subcutaneous Injection in 2008 for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond 4 months has not been studied.
Source: press release, 4/25/12. http://www.salix.com/news-media/news/index/salix-and-progenics-announce-...

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Together with Salix we have applied to the U.S. Food and Drug Administration to expand the population that can be treated with subcutaneous RELISTOR to include patients taking opioids for non-cancer pain, and who suffer from OIC as a result. This population includes patients taking opioids for conditions such as back pain or joint pain. The FDA’s action date on this marketing application under the Prescription Drug User Fee Act (PDUFA) is April 27, 2012.
Source: FORM 10K, 3/15/12. http://www.sec.gov/Archives/edgar/data/835887/000083588712000012/form10_...

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Progenics and Salix Announce FDA Acceptance of sNDA Filing for RELISTOR® in Patients with Non-Cancer Pain

— PDUFA Action Date is April 27, 2012 —

TARRYTOWN, N.Y. & RALEIGH, N.C.--(BUSINESS WIRE)-- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) and Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain. The FDA has issued an action date of April 27, 2012 under the Prescription Drug User Fee Act (PDUFA).
Source: press release, 8/30/11. http://www.progenics.com/releasedetail.cfm?ReleaseID=601998

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Progenics Submits RELISTOR(R) Supplemental NDA for the Treatment of Opioid-Induced Constipation in Patients With Chronic, Non-Cancer Pain

TARRYTOWN, N.Y., June 28, 2011 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of RELISTOR® (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

RELISTOR is the first approved medication that specifically targets the underlying cause of OIC. It is currently approved and sold in the United States, European Union, Canada, Australia and other countries for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

"This regulatory submission is an important milestone for Progenics as we work with our development and commercialization partner, Salix Pharmaceuticals, to make RELISTOR available to a broader population of patients," said Mark R. Baker, chief executive officer of Progenics.
Source: press release, 6/28/11. http://www.progenics.com/releasedetail.cfm?ReleaseID=587620

Mechanism of action: Relistor Methylnaltrexone (Sq), a SM-inhibitor, relieves the side effects associated with prolonged opioid exposure by blocking peripheral mu-opioid receptors with a methylated (unable to cross the BBB) version of the known opioid receptor antagonist naltrexone.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2012-07-27

Results:

Salix and Progenics Receive Complete Response Letter from FDA for RELISTOR® sNDA

RALEIGH, N.C. & TARRYTOWN, N.Y.--(BUSINESS WIRE)-- Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today received at approximately 5:00 p.m. ET a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of a Supplemental New Drug Application (sNDA) for RELISTOR ® (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL.

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 while retaining the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat constipation in patients with advanced illness and receiving palliative care, when response to laxative therapy has not been sufficient.
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Source: press release, 7/27/12. http://www.progenics.com/releasedetail.cfm?ReleaseID=696241