TARRYTOWN, N.Y., June 11, 2014 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that NASDAQ has halted trading of the company's common stock.
The U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee is meeting today and tomorrow, June 11 and 12, to discuss the potential cardiovascular risk associated with products in the class of peripherally-acting opioid receptor antagonists and the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain.
The Advisory Committee meeting is scheduled for 8:00 a.m. Eastern Time today. The briefing materials can be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm390304.htm. The Advisory Committee was originally announced in June 2013 in response to the appeal by Progenics' collaboration partner, Salix Pharmaceuticals (Nasdaq:SLXP), of the U.S. Food and Drug Administration's July 2012 Complete Response Letter in respect of Salix's supplemental New Drug Application for Relistor® subcutaneous injection for treatment of opioid-induced constipation in patients with chronic non-cancer pain. The FDA has stated that it will take action under the appeal within 30 days after receiving input from the Committee.
For more information concerning the Advisory Committee, please see Item 1 – Business – Relistor in the Company's 2013 Annual Report on Form 10-K and its first quarter 2014 Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission, as well as information disseminated by the FDA and/or available on its website.
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Salix Pharmaceuticals, Ltd. Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness.
Important Safety Information for subcutaneous Relistor
Relistor is indicated 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 four months has not been studied.
Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with Relistor and consult their physician. Use of Relistor has not been studied in patients with peritoneal catheters.
Safety and efficacy of Relistor have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).
Use Relistor with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with Relistor and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
The most common adverse reactions reported with Relistor compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%).
Relistor full Prescribing Information for the U.S. is available at www.relistor.com.
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics' first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic in a phase 2 clinical trial and a small molecule targeted imaging agent that has just completed a phase 2 trial. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate also in a phase 2 study under an SPA. Progenics' first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. For additional information, please visit www.progenics.com.
This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this press release as of its date and does not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise.
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Source:Progenics Pharmaceuticals Inc.