Onzetra XsailTreatment for Migraine
Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study
ALISO VIEJO, Calif., Oct. 30, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the publication of results from TARGET, a pivotal phase III study evaluating the efﬁcacy and safety of AVP-825 22mg in the January 2015 issue of Headache (Early access is now available). AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder (22mg) delivered intranasally utilizing a novel Breath Powered™ delivery technology, for the acute treatment of migraine. A New Drug Application (NDA) for AVP-825 has been accepted and is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of November 26, 2014.
"Some studies indicate that nearly half of the 37 million Americans suffering from migraines are dissatisfied with their current treatment. We believe AVP-825 could provide a targeted, fast acting migraine treatment option by combining low-dose sumatriptan, the most widely used prescription migraine medication, with an innovative delivery method," said Joao Siffert, MD, chief medical officer for Avanir. "We are pleased to have the pivotal trial data published in a reputable medical journal and look forward to the upcoming FDA decision in November and to potentially being able to offer a new migraine treatment to patients in need."
The TARGET study data demonstrated relief of moderate or severe migraine headache as quickly as 15 minutes (19.4% AVP-825 vs. 14.4% placebo device) in subjects receiving AVP-825). A significantly greater proportion of AVP-825 patients reported headache relief at 30 minutes (41.7% vs. 26.9%, P=0.03) and at every time point up to two hours post-dose compared with those using the placebo device (67.6% vs. 45.2%, P=0.002). Relief was sustained through 24 and 48 hours in a greater proportion of patients who received AVP-825 vs. placebo. The treatment was well tolerated with a low incidence of adverse events (AEs), with the most common AEs being product taste (22%), nasal discomfort (13%), and rhinitis (3%); local AEs were transient and almost exclusively mild to moderate in severity.
About the Phase III TARGET Study
In this multicenter, double-blind, placebo-controlled study, 230 migraine sufferers were randomized to self-administer either AVP-825 or placebo using the Breath Powered device when they had moderate to severe migraine pain. Pain scores were then assessed at various time points after administration. Pain was evaluated using a four point scale with headache relief defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete relief (grade 0).
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder (22mg) delivered intranasally utilizing a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine. AVP-825 is an investigational drug-device combination product not approved by the FDA. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.
The Breath Powered delivery technology is activated by user's breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing or inhalation of sumatriptan powder into the lungs.
Migraine represents an area of significant unmet medical need. According to the Centers for Disease Control and Prevention, over 37 million Americans suffer from migraine headaches. The triptan class of medications is generally considered the standard of care with over 13 million prescriptions written annually. Sumatriptan is the class leader and the most commonly prescribed migraine drug in the U.S. with a market share of over 50% making 100 mg tablets the most commonly prescribed form of sumatriptan. In a recent study, over 40 percent of migraine patients reported that they were not satisfied with their current medication and that 80 percent are willing to try another medication.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements relating to the potential effectiveness and/or safety of AVP-825, the timing for an FDA approval and the prospects for commercial success and adoption, if approved by the FDA. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Avanir's operating performance and financial position, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, obtaining additional indications, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Source: Avanir Pharmaceuticals, Inc.
Posted: October 2014
- FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine - January 28, 2016
- Avanir Pharmaceuticals Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA - November 26, 2014
- Avanir Pharmaceuticals Announces Preliminary Feedback from the FDA on AVP-825 for the Acute Treatment of Migraine - November 7, 2014
- Avanir Pharmaceuticals Announces Acceptance of NDA for AVP-825 for the Acute Treatment of Migraine - March 26, 2014
- Avanir Pharmaceuticals Announces Submission of New Drug Application for AVP-825 for the Acute Treatment of Migraine - January 30, 2014
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