|Sucampo Announces Approval for Updates to AMITIZA; Endo Health Solutions Stock Halted Following News|
|By Staff and Wire Reports|
|Friday, 30 November 2012 19:53|
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) announced the Company received a supplement approval from the U.S. Food and Drug Administration (FDA) that removes pregnancy “warnings and precautions” and clarifies information regarding the use of AMITIZA^® (lubiprostone) by pregnant and/or nursing women. In addition, the FDA expanded the labeling text of the Mechanism of Action section in the prescribing information for AMITIZA. AMITIZA is approved for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older (8 mcg twice daily).
The Company also announced today that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency's priority review of the supplemental new drug application (sNDA) filing seeking approval for an additional indication for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. Sucampo was notified that its November 16, 2012 submission of FDA-requested supportive analyses has been designated as a major amendment to the application. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has decided to extend the goal date by three months to provide time for a full review of the submission. The extended user fee goal date is late April, 2013. No new clinical trials or studies have been requested by the FDA.
Sucampo has accepted the following FDA-approved labeling changes, which will be effective immediately:
1. All pregnancy-related Warnings and Precautions (Section 5.1 of the label) have been removed. This includes deletion of the sentence: “Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.” 2. Section 8 of the product labeling, “Use in Specific Populations,” was updated to include additional animal data and a Clinical Consideration section, with the pregnancy category remaining unchanged. 3. Previous labeling statements regarding the potential for serious adverse reactions in nursing infants have been removed. The revised label states that caution should be exercised when AMITIZA is administered to a nursing mother and advises “lactating women to monitor their human milk-fed infants for diarrhea while taking AMITIZA.” 4. The Mechanism of Action section (Section 12.1) of the label now reads as follows: “Lubiprostone is a locally acting chloride channel activator…activation of ClC-2 by lubiprostone has been shown to stimulate recovery of mucosal barrier function and reduce intestinal permeability (bolding added to indicate label addition) via the restoration of tight junction complexes in ex vivo studies of ischemic porcine intestine.”
Endo Health Solutions Inc. (Nasdaq: ENDP) announced its subsidiary, Endo Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) seeking a formal determination whether the original formulation of OPANA® ER (oxymorphone HCl) was voluntarily removed from the market in 2012 for reasons of safety involving the misuse of the drug; and FDA's immediate suspension of any abbreviated new drug applications (ANDAs) for generic versions of non-tamper resistant formulations of extended-release oxymorphone HCl until FDA has made a determination as to whether the original formulation of OPANA ER was withdrawn from sale for safety reasons. There is currently a non-tamper resistant generic of extended-release oxymorphone available in 7.5mg and 15mg dosage strengths, and if the FDA does not promptly suspend the approval of all non-tamper resistant formulations, all doses of the product will be available in non-tamper resistant versions in January 2013.
Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012. Current data monitoring abuse rates show a substantial decrease in abuse since the launch of the reformulated product, while simultaneously showing a more than 122 percent increase in abuse rates of the 7.5mg and 15mg non-tamper resistant extended release oxymorphone HCl.
The lawsuit, filed in the U.S. District Court for the District of Columbia, is based on the failure of the FDA to meet its legal obligation to determine in a timely manner whether the old formulation of OPANA ER was withdrawn from the market for reasons of safety. Since its launch, Endo has collected surveillance data on the rates of abuse of oxymorphone HCl from two national programs – the first includes surveillance of substance abusers and the second collects data from U.S. Poison Control Centers. The data show a 59 percent drop in abuse rates of the reformulated OPANA ER which is designed to be crush-resistant. The same data demonstrate a 122 percent increase in abuse rates of non-tamper resistant extended-release oxymorphone HCl.
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