FDA Approves Osmolex, by Osmotica, to Treat Movement Problems in Parkinson’s and Other Adults

The U.S. Food and Drug Administration (FDA) has approved Osmolex ER (amantadine, extended release) to treat both Parkinson’s disease and therapy-induced extrapyramidal reactions in adults, or the movement and muscle-control problems that typify this disease and can be side effects of common medications.

Osmodex ER, developed and marketed by Osmotica Pharmaceutical, is a once-daily tablet that contains a combination of immediate release and extended release amantadine (its active agent). Osmotica uses its patented Osmodex technology that combines laser-drilled tablet technology with a variety of single-active and multiple-active drug delivery devices,  the company states in a press release.

The Osmodex technology is a potential solution for soluble low-bioavailability medicines or for those that require a targeted delivery, as it simplifies dosing and may aid in patient compliance.

The Osmolex ER tablet is taken in the morning, and provides a controlled release of amantadine throughout the day, the company states. The therapy is available as three dosage options – 129 mg, 193 mg and 258 mg tablets – with the intent that physicians can decide the best dose for each patient, up to a maximum daily dose of 322 mg.

“The FDA’s approval of OSMOLEX ER provides a new treatment option for those patients suffering from Parkinson’s disease and adults who have extrapyramidal reactions, or movement disorders, that are caused by certain medicines. We are eager to make OSMOLEX ER available to physicians and patients in the U.S.,” Brian Markison, chief executive officer of Osmotica, said in the release.

Plans are to begin marketing the treatment “as soon as possible,” Markison added.

Amantadine as a Parkinson’s treatment was first developed and marketed by Adamas Pharmaceutical. An extended-release version of the company’s therapy, sold under the name of Gocovri, was approved by the U.S. Food and Drug Administration (FDA) to treat dyskinesia (involuntary and uncontrollable movements) in Parkinson’s disease patients who are receiving levodopa-based therapy, alone or combined with other medications, in August 2017.

Amantadine blocks glutamate’s access to certain receptors in the brain, reducing their signaling and therefore the level of dyskinesia.