Amneal to market Ongentys, for Parkinson’s off periods, in US

Add-on treatment to levodopa and carbidopa to ease symptoms like dyskinesia

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by Andrea Lobo |

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Amneal Pharmaceuticals and Bial have entered into a licensing agreement giving Amneal exclusive rights to market and distribute Ongentys (opicapone) in the U.S. as an add-on treatment for people with Parkinson’s disease.

Owned by Bial, Ongentys was approved by the U.S. Food and Drug Administration (FDA) in 2020 as a carbidopa and levodopa add-on therapy for people experiencing off episodes — times when medication wears off and motor fluctuations return between doses.

Amneal expects to start distributing Ongentys early next year.

“Our partnership will allow us to expand its accessibility, continuing to make a difference for patients suffering from Parkinson’s disease in the U.S.,” Max Bricchi, Bial’s executive vice president and chief commercial officer, said in a company press release.

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Ongentys helps to prevent the off episodes tied to levodopa/carbidopa use

Parkinson’s disease is caused by the progressive dysfunction and death of dopaminergic neurons, the nerve cells responsible for producing dopamine, which primarily are found in a part of the brain called substantia nigra.

Dopamine is a neurotransmitter, a chemical that neurons use to communicate with each other. The loss of dopaminergic neurons leads to impaired dopamine signaling in the brain, and hallmark Parkinson’s disease symptoms.

Levodopa is the gold standard treatment for easing Parkinson’s motor symptoms, including tremors, rigidity, and bradykinesia (slowness of movement). Levodopa is a precursor of dopamine, and it can be converted to dopamine in the brain.

It usually is given in combination with substances that inhibit the actions of DOPA decarboxylase (DDC) and catechol-o-methyl transferase (COMT), two enzymes responsible for transforming levodopa into dopamine in the body before it reaches the brain. Carbidopa, a DDC suppressor, commonly is combined with levodopa and works to enhance the amount of levodopa that reaches the brain.

The combination allows for a lower levodopa dose, helping to prevent side effects like dyskinesia (sudden, uncontrolled movements). But as the disease progresses, a patient’s response to levodopa typically diminishes and off periods become more common. A higher levodopa dose can be taken, but higher doses often lead to such side effects.

Ongentys, a COMT inhibitor, is an oral adjunctive treatment to levodopa/carbidopa that helps to make off episodes less frequent.

The treatment also has been available in Europe since 2016, where it is marketed by Bial, and it was approved in Japan in June 2020.

According to Amneal, the treatment also is highly complementary to its investigational therapy IPX203 and to its approved treatment Rytary, two extended-release formulations of carbidopa and levodopa.

“We understand the importance of minimizing ‘Off’ time and increasing ‘On’ time [when symptoms are well controlled with medication] without troublesome dyskinesia when treating [Parkinson’s disease]. We look forward to working with BIAL to ensure Ongentys remains available for patients in the U.S.,” said Joe Renda, Amneal’s senior vice president and chief commercial officer specialty.

The financial terms of the agreement were not disclosed.