|Teva Presents Positive Safety and Efficacy Data for QNASL®; Avanir Announces Preliminary Feedback from the FDA on AVP-825|
|By David Fowler|
|Friday, 07 November 2014 18:54|
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced positive findings from a Phase III clinical study which examined the safety and efficacy of QNASL® (beclomethasone dipropionate) Nasal Aerosol 80 μg/day in children 4-11 years of age with perennial – or “year round” – allergic rhinitis (PAR). QNASL is a waterless aerosol intranasal corticosteroid spray currently available for the treatment of PAR and seasonal allergic rhinitis (SAR) in patients 12 years of age and older. The data will be presented at the 2014 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Atlanta, Georgia on Saturday, November 8 and Sunday, November 9.
“As a company deep-rooted in its commitment to helping people living with respiratory conditions, such as allergic rhinitis, we look forward to the potential for bringing this new, specially formulated treatment option to market,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “It is our goal at Teva to address patients’ unmet needs and we believe these findings support QNASL as a prospective treatment for children suffering from the symptoms associated with nasal allergies.”
On May 13, 2014, the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application (sNDA) for a lower dose QNASL for the treatment of PAR and SAR in children 4-11 years of age. The submission was based on a comprehensive clinical development program consisting of three Phase III clinical trials designed to evaluate the safety and efficacy of QNASL 80 μg/day in children with allergic rhinitis (AR). If approved, QNASL will be the first and only waterless HFA nasal allergy treatment available for patients as young as four years of age.
“Since there are limited new treatment options available to help manage allergic rhinitis in the pediatric patient population, it is certainly exciting to see these results for QNASL,” said study investigator Dr. William Berger of the Allergy and Asthma Associates of Southern California in Mission Viejo, California. “This treatment features a low-dose formulation and ‘waterless’ aerosol delivery, making it a promising option for children with allergic rhinitis.”
The 12-week, Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trial enrolled 547 patients ages 4 to 11 to receive two actuations (one 40 μg/actuation per nostril) of QNASL or placebo nasal aerosol once daily. Symptoms were measured at 6 weeks and 12 weeks using average morning (AM) and evening (PM) reflective and instantaneous nasal symptom scores. Results indicate that patients treated with QNASL experienced a significantly greater improvement in PAR symptoms than patients treated with placebo. Overall, QNASL was well tolerated throughout the duration of the study with a safety profile comparable to placebo.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced the U.S. FDA has issued preliminary written feedback to its New Drug Application (NDA) for AVP-825. AVP-825 is a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally utilizing a novel Breath Powered delivery technology. The FDA has raised questions regarding the human factor validation study data submitted as part of the NDA. Human factor testing focuses on the interactions between people and devices. The goal of human factor testing is to evaluate use-related risks and confirm that users can use the device safely and effectively. Although the NDA review is ongoing, Avanir has concluded, at this time, that approval of AVP-825 may be unlikely by the PDUFA date of November, 26, 2014.
The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle to convey early thoughts on possible deficiencies of an application. In the letter, the FDA requested that the company optimize the product-user interface and conduct additional human factor testing. In addition, the FDA commented that the NDA review is not complete and that they may have additional comments regarding the application.
"We are currently reviewing the correspondence from the FDA and are awaiting the final feedback when the full NDA review cycle is complete on November 26th," said Joao Siffert, MD, chief medical officer of Avanir. "We plan to work closely with the FDA to answer the agency's questions and satisfy their requirements. We remain confident that AVP-825 will be an important new treatment option for migraine patients who are in need of alternative, fast acting and well tolerated medications."
About AVP-825 -- 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 the most commonly prescribed migraine medication. 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.
About Migraine -- 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 with a market share of over 50% making it the most commonly prescribed migraine drug in the U.S. 100 mg tablets are the most commonly prescribed form of sumatriptan. In a clinical study, over 40% of patients were not satisfied with the degree of relief they experienced from their current prescription migraine medications and nearly 80% of them were willing to try another medication. As a result, many migraine sufferers are seeking new fast-acting, well tolerated treatment options.
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