–Company Plans to Complete a New Human Factor Validation Study and Respond to the CRL in the First Half of Calendar 2015–
ALISO VIEJO, CA, USA I November 26, 2014 I Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for AVP-825. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology.
In the Complete Response letter, and consistent with the preliminary feedback announced on November 7, 2014, the FDA requested that Avanir assess the root cause(s) of device use errors observed in the previously conducted human factors testing. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively. A new human factors validation study will be required to assess usability of the device following improvements. The FDA did not find any clinical or non-clinical safety or efficacy issues nor chemistry, manufacturing, and controls (CMC) issues. The FDA did not request that any additional clinical trials be conducted prior to approval.
“We believe the concerns raised by the FDA are fully addressable,” said Joao Siffert, MD, chief medical officer of Avanir. “Following the receipt of the preliminary feedback we have been working internally and with the FDA toward implementing changes prior to repeating the human factors study. Based on these conversations, we will conduct a new human factors study, with input from the FDA, with a goal to respond to the CRL in the first half of calendar 2015.”
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.
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.
Avanir® is registered trademarks owned by Avanir Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.
Avanir Pharmaceuticals, Inc. licensed exclusive rights for the development and commercialization of AVP-825, a novel Breath Powered intranasal system containing a low-dose sumatriptan powder from OptiNose AS.
SOURCE: Avanir Pharmaceuticals
Post Views: 29
–Company Plans to Complete a New Human Factor Validation Study and Respond to the CRL in the First Half of Calendar 2015–
ALISO VIEJO, CA, USA I November 26, 2014 I Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for AVP-825. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology.
In the Complete Response letter, and consistent with the preliminary feedback announced on November 7, 2014, the FDA requested that Avanir assess the root cause(s) of device use errors observed in the previously conducted human factors testing. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively. A new human factors validation study will be required to assess usability of the device following improvements. The FDA did not find any clinical or non-clinical safety or efficacy issues nor chemistry, manufacturing, and controls (CMC) issues. The FDA did not request that any additional clinical trials be conducted prior to approval.
“We believe the concerns raised by the FDA are fully addressable,” said Joao Siffert, MD, chief medical officer of Avanir. “Following the receipt of the preliminary feedback we have been working internally and with the FDA toward implementing changes prior to repeating the human factors study. Based on these conversations, we will conduct a new human factors study, with input from the FDA, with a goal to respond to the CRL in the first half of calendar 2015.”
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.
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.
Avanir® is registered trademarks owned by Avanir Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.
Avanir Pharmaceuticals, Inc. licensed exclusive rights for the development and commercialization of AVP-825, a novel Breath Powered intranasal system containing a low-dose sumatriptan powder from OptiNose AS.
SOURCE: Avanir Pharmaceuticals
Post Views: 29
