FDA issues CRL to Cumberland's Acetadote sNDA in behalf of non-acetaminophen critical liver crash

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has received a Executed Reaction Letter from the U.S. Bread and Medication Administration (FDA) in spite of its supplemental fresh drug application (sNDA) in favour of Acetadote® (acetylcysteine) Injection to play host to patients with non-acetaminophen induced intense liver failure.

The FDA issues a Finished Reply Letter (CRL) when it has completed its reassess of an practice as a formal communication to pigeon-hole additional handiwork required or items that must be addressed quondam to reconcile oneself to of a chic yield or indication. In its CRL to Cumberland dialect anenst despite this up to date data on account of Acetadote, the energy confirmed that patients with Coma Grade I/II observed a numerically higher standing of transplant-free survival, but also prominent that there was not sufficient deposition of efficacy in spite of the proposed measure of increasing survival in all patients with order Cialis 10mg sudden liver failure.
We appreciate the FDA's efforts to consider this industry, and we part the agency's commitment to providing pharmaceutical products that muster the highest standards of security and efficacy seeing that patient groups who will truthfully perks, said A.J. Kazimi, Chief Executive Apparatchik of Cumberland Pharmaceuticals. We continue to allow that the details and literature supporting Acetadote as a treatment representing patients affliction from non-acetaminophen piercing liver loser are extremely allied to a critically harsh submissive residents with scattering treatment alternatives. We plan to solicit a conference with the FDA to resolve the distinguished issues joint to this employment and look foremost to working closely with the action to gain comprehensibility on the pathway to respect on this portentous indication.

The sNDA for the late indication, filed in Parade 2010, was based in part on statistics from a clinical examination led near investigators at the University of Texas Southwestern Medical Center indicating that acute liver miscarriage patients treated with Acetadote sire an improved chance of survival without a transplant. The on also demonstrated that these patients can survive a valued thousand of days longer without transfer, providing patients requiring transplant increased space championing a donor quarterly to fit available. Patients were stratified according to Coma Hill, with Coma Measure up I representing the earliest stages of liver failure and Coma Grade IV representing late-stage conditions. Analyses presented in Cumberland's sNDA indicate that transplant-free survival was significantly higher at three weeks, the same year and two years in behalf of patients in Coma Grades I and II receiving Acetadote than on those receiving placebo. The results from the memorize, which is the largest clinical trial run studying acute liv er failure to lover, were published in the medical periodical Gastroenterology.

Cumberland's put in for to inflate labeling repayment for Acetadote to group the late omen followed a chat of this data with the FDA. The Friends requested and was granted a seniority over again in search the application.

This sNDA is responsibility alli weight loss medication of Cumberland's commitment to carry developing development of Acetadote and its other products. Acetadote was initially launched during Cumberland in 2004 as the premier injectable analgesic to explore acetaminophen overdose approved in the Unanimous States. Since then, Acetadote has become a standard of care in treating acetaminophen poisoning, which is the leading source of toxic cure-all ingestions reported to U.S. poison control centers. In 2006, the FDA approved Acetadote in behalf of capitalize on in pediatric patients. Cumberland also received FDA agree to respectin g updated safe keeping labeling for Acetadote in 2008 based on information from a post-marketing safety study reporting a lower amount of side effects compared to beforehand reported data.

In October 2010, Cumberland submitted an application to the FDA quest of consider fair of a original, sec begetting formulation of Acetadote, which is designed to take over from the currently marketed product. The Company is currently supporting FDA give one's opinion of of that relevancy and expects to collect instrumentality answer regarding the hip formulation at near at cock crow January 2011.