Project name: eslicarbazepine acetate
Peak sales estimate: Not available
Approved: Nov. 8
Company: Sunovion Pharmaceuticals
Sunovion Pharmaceuticals ($SEPR), formerly Sepracor, gained FDA approval in November for its antiepileptic add-on drug Aptiom to treat seizures. The win adds one more central nervous system (CNS) therapy to the Marlborough, MA-based company's growing list of approved drugs.
Aptiom is approved to treat so-called partial seizures, the most common type of seizure seen in people with epilepsy. A brain disorder stemming from abnormal or excessive activity in the brain's nerve cells, epilepsy can cause seizures that exhibit a wide range of symptoms--repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Severe seizures can also cause injury and death.
Epilepsy is one of the most common neurological disorders and, according to the Centers for Disease Control and Prevention (CDC), affects nearly 2.2 million people in the U.S. Partial-onset seizures are the most prevalent seizure type, making up 60% of new epilepsy diagnoses. About 200,000 new cases of seizures and epilepsy occur in the U.S. each year.
"Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments," said Dr. Eric Bastings, acting director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in a statement.
Sunovion noted at the time the therapy was approved that the company expects Aptiom to be available in U.S. pharmacies sometime in the second quarter of 2014.
Aptiom was studied in three clinical trials in patients with partial epilepsy. Participants that were randomly assigned to receive Aptiom had less frequent seizures than those taking a placebo had.
Like other antiepileptic drugs, Aptiom's side effects may include suicidal thoughts or actions and new or worsened anxiety or depression in a very small number of patients.
In June last year, Sunovion won FDA approval for the antipsychotic drug Latuda to treat bipolar disorder in adults. Latuda had been approved in 2010 to treat adult patients with schizophrenia. Sunovion also markets the widely prescribed sleep-aid drug Lunesta.
In 2009, Sepracor was acquired by Japan's Dainippon Sumitomo Pharma--a move that strengthened DSP's North American-based drug development pipeline and commercial capabilities. The acquisition brought together two main treatment categories--CNS disorders and respiratory diseases.
Sunovion emerged in 2010 when DSP's original U.S. subsidiary, Dainippon Sumitomo Pharma America, was merged into Sepracor. Last year, the newly formed Sunovion put down $100 million to buy San Diego-based Elevation Pharmaceuticals and its lead drug EP-101 for COPD, promising $90 million in research milestones, $210 million in commercial milestones and another $30 million contingent upon the further development of additional new programs.
Aptiom represents new revenue potential for Sunovion, whose patent for the asthma inhalation solution Xopenex expired in August of 2012. Lunesta's patent is set to expire in April 2014. -- Emily Mullin (email | Twitter)
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