FDA Approves Zingo for Adults
Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults
SOUTH SAN FRANCISCO, January 09, 2009 /PRNewswire-FirstCall/ -- Anesiva, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Anesiva's supplemental New Drug Application (sNDA) to expand the indication for Zingo to treat the pain associated with blood draws to include adults. Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system was previously approved to treat the pain associated with peripheral IV insertions and blood draws in children three to 18 years of age. The notification was received according to PDUFA deadlines.
As announced in November 2008, Anesiva ceased Zingo commercial activities to focus on the development of Adlea, its novel non-opioid, long-acting analgesic drug candidate for the management of acute pain following orthopedic surgeries. Anesiva is seeking to license Zingo as well as the underlying drug delivery technology and intellectual property.
Anesiva, Inc. seeks to be a leader in the development and commercialization of novel pharmaceutical products for pain management. Anesiva's lead product candidate is Adlea, a novel small molecule formulation of capsaicin that is currently in development for the management of acute pain following orthopedic surgeries. Adlea has been shown in clinical trials to provide extended pain relief after only a single administration in multiple indications for site-specific, acute and chronic, moderate-to-severe pain.
In December 2008, Anesiva announced that a Phase 3 trial of Adlea achieved its primary efficacy endpoint of reduced post-surgical pain versus placebo (p=0.03) following total knee arthroplasty (TKA, or total knee replacement surgery) at four to 48 hours after surgery. The trial also met its key secondary endpoint with Adlea demonstrating a highly significant reduction in opioid medication consumption compared to placebo (p=0.005).
The Phase 3 TKA trial, known as ACTIVE-2 (Assessment of highly purified Capsaicin To ImproVE pain management after orthopedic surgery), also showed that Adlea's safety profile of adverse events, wound healing, and wound sensory function were similar to placebo over the study duration.
Anesiva is based in South San Francisco, CA.
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "seek" and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: the nature and extent of additional Adlea clinical trials that may be required by the FDA prior to Anesiva's submission of an application for approval to market Adlea, whether any clinical trials will be successful, and the ability to identify and successfully complete a strategic transaction for the assets related to Zingo. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's annual report on Form 10-K for the year ended December 31, 2007, and its most recent filing on Form 10-Q.
Posted: January 2009
- Anesiva Receives FDA Approval for Zingo, a New, Innovative Productto Reduce Pain Associated with Needle Insertion Procedures inChildren - August 17, 2007
- Endo Comments on Notices Received From Anesiva Regarding Zingo - April 10, 2007
- Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children - February 7, 2007
- Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children - November 27, 2006