February 1, 2016
By Alex Keown, BioSpace.com Breaking News Staff
ALISO VIEJO, Calif. – The U.S. Food and Drug Administration’s approval of Avanir Pharmaceuticals ’ Onzetra migraine medication has pushed the company to the next level it had been seeking.
On Friday, federal regulators approved the migraine medication, delivered as a nasal inhalant. Onzetra (sumatriptan nasal powder) is a fast-acting dry powder formulation of sumatriptan, the most commonly prescribed migraine medication. Formerly known as AVP-825, Onzetra is delivered in a unique manner through the company’s Xsail technology. Its mechanism is akin to traditional nasal inhalants, but the delivery actually uses the patient’s own breath to blow the medication up the nose. By using the patient’s breath, Rohan Palekar, the new chief executive officer of Avanir Pharmaceuticals, said more medicine will actually get to where it’s supposed to go rather than ending up down the patient’s throat.
“By using the body’s properties, it will cause the throat to close when blown and deliver more drug to the nasal cavity than traditional nasal sprays,” Palekar told BioSpace last week in an exclusive interview.
Palekar said he has a vision to guide the company to becoming a multi-product provider of therapies for central nervous system (CNS) diseases and address unmet therapeutic needs, including migraines. Stewart Tepper, professor of neurology at the Geisel School of Medicine at Dartmouth, said in a statement that approximately 70 percent of migraine sufferers are not happy with their current treatments.
“Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people,” said Roger Cady, director of the Headache Care Center and associate executive chairman of the National Headache Foundation.
Onzetra’s approval came after patients in clinical trials successfully self-administered the drug. Data from the trial showed patients reported headache relief at 30 minutes and at every time point up to two hours post-dose compared with those who used the placebo.
Avanir, a division of Otsuka America, has one other approved product, Nuedexta, for the treatment of pseudobulbar affect, a neurological disorder often characterized by involuntary crying or uncontrollable laughter. In addition to unmet needs in migraine headaches, Avanir is also targeting other unmet needs, including agitation in Alzheimer’s patients and other forms of dementia with a new generation of Nuedexta that requires lower doses in patients.
“This is a huge unmet area. There are currently no approved drugs on the market. Agitation is the number one cause for institutionalization in the United States,” Palekar said. He added it is difficult for the loved ones of an agitated dementia patient to provide in-home health care, but the new drug, if approved, could help control the level of institutionalization.
Additionally, the company completed a Phase II trial for a treatment for treatment-resistant depression, which Palekar also described as an unmet need. He said most of the current approved treatments target the same mechanism, the glutamate pathway for depression, but Avanir believes it has found a different pathway for treatment. Palekar said the company will have to wait for the trial data to see if they are on the correct path. Palekar said the goal of Avanir is to build a strong franchise in mood and behavior disorders and he believes the company is well on its way.
