logo
Plus   Neg
Share
Email

Jazz Pharma Gets FDA Nod For Sleep Disorder Drug Sunosi

The FDA has approved Jazz Pharmaceuticals plc's (JAZZ) once-daily Sunosi for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

Sunosi in doses of 75 mg and 150 mg is approved for patients with narcolepsy, and in doses of 37.5 mg, 75 mg, and 150 mg, it is approved for patients with obstructive sleep apnea.

Some of the other approved drugs for excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea include Modafinil and Armodafinil.

Jazz Pharma's Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to treat excessive daytime sleepiness in adults living with narcolepsy or obstructive sleep apnea.

The Company acquired a license to develop and commercialize Sunosi from Aerial Biopharma in 2014.

The drug is expected to be commercially available in the U.S. following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA), which is typically within 90 days of FDA approval.

JAZZ closed Wednesday's trading at $133.57, down 1.46%.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT