February 22, 2018
A company developing novel central nervous system treatments has received FDA approval for an extended-release tablet to treat Parkinson disease (PD) and drug-induced extrapyramidal reactions in adult patients.
The company, Osmotica Pharmaceutical US LLC, uses its proprietary osmotic drug delivery platform in their drug development.
The new drug, OSMOLEX ER™, is made up of a combination of immediate-release and extended-release amantadine and represents a new once-a-day approach to the treatment of PD and drug-induced involuntary movements in adults. The tablet is to be taken once-daily in the morning, releasing amantadine throughout the day. Tablets will be available in 3 dosing options with the initial dosage being 129 mg.
Osmotica CEO Brian Markson said, “We are currently finalizing our plans to commercialize the product and ensure patients and providers have access as soon as possible” (Osmotica Pharmaceutical press release, February 19, 2018).
The drug is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2. Warnings accompanying the drug in the package insert include falling asleep during activities of daily living, suicide and depression, hallucinations/psychotic behavior, dizziness and orthostatic hypotension, withdrawal-emergent hyperpyrexia and confusion, and impulse control/compulsive behaviors.
—Amanda Del Signore
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