Achelios Therapeutics concludes successful Type C meeting with FDA regarding Topofen

Currently there are no approved topical NSAIDs indicated for the treatment of migraine.

Achelios' recently completed Phase IIa study demonstrated that the topical application of a well-known non-steroidal anti-inflammatory drug (NSAID) to facial areas innervated by trigeminal nerve branches may be a safe and effective alternative treatment for patients suffering from acute migraine. For the Type C meeting Achelios sought confirmation of the requirements for Phase III and New Drug Application (NDA) submission. Currently there are no approved topical NSAIDs indicated for the treatment of migraine.

"This new FDA guidance confirms our previous interactions with the agency, provides for a streamlined development path to approval, and is consistent with our previous guidance and with the FDA regulations for a 505(b) 2 NDA application," said John G. Fort, the company's chief medical officer. "Based on the streamlined clinical trial requirements, Achelios will be able to achieve an NDA filing in a relatively quick and cost-effective manner compared to what is typically required for a new chemical entity (NCE)."

Wolfgang Liedtke, from Duke University is a member of the team that conducted the research, and a paid advisor to Achelios. Liedtke, a tenured professor of neurology, anesthesiology and neurobiology and attending physician at Duke University, said: "The results of the study are encouraging, and those of us who treat migraine think it may lead to a meaningful alternative treatment for a substantial number of migraineurs. This study showed that it may be possible to affect severe migraine, which can be a debilitating neurological pain condition, with a topical application to facial trigeminal nerve endings."

Crist Frangakis, the company's president and CEO, said: "Topofen represents a novel approach for the acute treatment and prophylaxis in chronic migraine, with unique benefits for the patient and importantly, given the intellectual property that has been both filed and granted, a patent-protected opportunity for a potential partner. We believe Topofen provides great value given its low required development costs and accelerated time to market relative to other potential new therapies. We also see Topofen as having tremendous value for patients outside of migraine, given the potential for additional indications such as temporomandibular joint diseas, post-operative inflammatory pain, chemotherapy-induced neuropathic pain and joint arthritis pain."