Parkinson

Parkinson’s Therapies Gocovri and Osmolex ER Now Part of Supernus

Supernus Pharmaceuticals’ portfolio of Parkinson’s disease therapies now includes Gocovri (amantadine) and Osmolex ER (amantadine hydrochloride), with the company’s acquisition of Adamas Pharmaceuticals now complete.

“Adamas fits squarely within our corporate development strategy, adding a late-stage commercial product with significant revenue,” Jack Khattar, president and CEO of Supernus Pharmaceuticals, said in a press release.

The acquisition is expected to boost Supernus’ growth in 2022 and follows a $450 million agreement — $50 million of which is contingent upon certain Gocovri sales milestones being achieved.

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Parkinson’s disease is characterized by the loss of dopamine-producing nerve cells, those responsible for releasing the neurotransmitter dopamine, a chemical messenger that allows nerve cells to communicate and also helps to regulate movement.

A short supply of dopamine in the brain causes both motor and non-motor symptoms observed in Parkinson’s.

Levodopa, which is a precursor to dopamine, has long been one of the gold standards for Parkinson’s treatment. It is converted into dopamine in the brain, since dopamine itself cannot cross the brain-blood barrier, a semi-permeable membrane that “shields” the brain from potential disease-causing pathogens and toxins that may be present in blood.

However, long-term levodopa therapy often results in dyskinesia, the involuntary and jerky movements that occur in Parkinson’s patients.

Gocovri is a long-acting and extended-release capsule that is recommended for those receiving levodopa-based therapy, with or without other dopaminergic medications. It was the first therapy approved in the United States for levodopa-induced dyskinesia. Its extended-release capsules treat dyskinesia, and can be used as an add-on treatment for “off” episodes, periods characterized by the reappearance or worsening of motor symptoms due to a gradual decline in levodopa’s effectiveness.

Recently, post-hoc analyses of data from clinical trials — including the Phase 3 trials EASE LID (NCT02136914) and EASE LID 3 (NCT02274766) — showed that Gocovri was better than other levodopa add-on treatments and amantadine formulations in lessening off episodes and dyskinesia in Parkinson’s patients.

Osmolex ER (extended-release capsule) is approved to treat Parkinson’s motor symptoms, including those caused by other therapies. Amantadine, the active ingredient in both Osmolex and Gocovri, eases the severity of movement and muscle control issues — called extrapyramidal reactions — often seen in patients on long-term use of medicines that affect dopamine receptors. Adamas acquired global rights to Osmolex ER late last year.

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