FDA Awards Final Approval to Entacapone Generic for Wearing-off

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by Margarida Maia, PhD |

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Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of entacapone as an add-on therapy for treating end-of-dose “wearing off” in Parkinson’s disease, the company announced.

These entacapone tablets are “therapeutically equivalent” to Comtan and treat the motor symptoms experienced by Parkinson’s patients when first-line therapies wear off, according to the India-based Alembic.

The company had filed an Abbreviated New Drug Application (ANDA) seeking approval to produce and market a generic version of Orion’s Comtan, which is sold in the U.S. by Novartis.

A generic medicine is one that works in the same way — and has comparable clinical benefit — as the brand-name medicine, but at a possibly lower cost. Like Comtan, the generic version will be available as tablets containing 200 milligrams (mg) of entacapone, to be taken by mouth.

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Some Parkinson’s Medicines May Hurt Levodopa Effectiveness

Many people with Parkinson’s experience fluctuations in motor and non-motor symptoms toward the end of the period between two doses of levodopa, which is the mainstay treatment for the neurodegenerative disease. Levodopa is a molecule that the body can convert into dopamine, a neurotransmitter whose lack in the brain causes the symptoms associated with the disease.

Fluctuations, also called “off” periods, occur when the effects of levodopa wear off and symptoms return. These off periods are linked to a reduction in the levels of dopamine in the brain, which means that the period of time during which the medications work well becomes shorter.

Entacapone is used in combination either with levodopa and carbidopa — a medication that helps increase the amount of levodopa available for transport into the brain — when a patient is having fluctuations and only when these fluctuations cannot be treated with the levodopa/carbidopa combo alone.

It works to restore the levels of dopamine in the brain by extending the time during which levodopa remains active. The medication does this by blocking the action of an enzyme called catechol-O-methyl transferase or COMT that breaks down levodopa in the body. This may help to lessen motor symptoms, such as stiffness and slowness of movement, and non-motor symptoms, such as anxiety.

According to the data technology company IQVIA, estimated total sales of entacapone tablets were $10.5 million in the one year ending September 2021.

In the last year, Alembic has received 13 final approvals for its ANDAs from the FDA, the company said.

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