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FDA approves AbbVie’s Duopa in advanced Parkinson’s

Drug is administered into the stomach via a tube
FDA headquarters

The US FDA has approved a version AbbVie's Duopa to be administered via the stomach for the treatment of motor fluctuations in advanced Parkinson's disease.

Duopa (carbidopa and levodopa) is given to patients over a 16-hour period by a pump via a tube that requires a small hole into the stomach directly into the small intestine.

Such a treatment method is sometimes necessary in advanced stages of Parkinson's where patients may experience 'off' periods of poor mobility and uncontrolled vomiting, which can affect the effectiveness of orally administered medicines.

The drug is recommended as an orphan drug due to rarity of its approved indication.

Michael Severino, executive VP of research and development and chief scientific officer at AbbVie, said: “The FDA approval of Duopa is another significant milestone for AbbVie's pipeline. This advancement is important for patients with advanced Parkinson's disease and their care teams, as it provides a new therapeutic option to help manage motor symptoms.”

Duopa provides patients with the same active ingredients as orally administered carbidopa and levodopa, but is designed to bypass the stomach and go directly into the small intestine.

C Warren Olanow, lead investigator of the Duopa pivotal trials, said: “There is an unmet need for treatment options for patients with advanced Parkinson's disease. As the disease advances, it can be difficult to control motor features.

“In clinical trials, Duopa was shown to significantly reduce the amount of off time advances Parkinson's disease patients experienced.”

Some side effects noted during the clinical trials include causing or worsening depression, inflammation of the pancreas and nausea, with some experiencing fever and confusion after suddenly stopping using Duopa.

Parkinson's disease remains an area of concern for many pharma companies and at the start of the year, Google-backed genetics company 23andMe entered a research agreement with Roche subsidiary Genentech to focus on generating whole genome sequencing data for around 3,000 people with Parkinson's disease.

Article by
Kirstie Pickering

21st January 2015

From: Sales



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