US FDA declines to approve Supernus' Parkinson's combination again (April 8)

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) - Supernus Pharmaceuticals said on Monday the U.S. FDA declined to approve its drug-device combination to treat movement-related symptoms of Parkinson's disease, sending its shares down 9% in early trade.

This is the second time the regulator has refused to approve, dealing a blow to the company's years-long effort to market its pump-based treatment.

The FDA has flagged two areas that require additional review and said Supernus' application was not ready for approval in its present form, the company said.

The regulator in 2022 refused to approve the product, citing the need for information related to labeling, product quality and manufacturing, device performance and risk analysis. It did not request additional efficacy and safety studies.

This time, it has requested for additional information related to product quality and the device, which continuously delivers drug under the skin compared to injections, commonly used to control symptoms.

The company plans to address the FDA's concerns and resubmit its application for the product, which aims to treat so-called "off episodes", which affects nearly all patients of Parkinson's, heightening symptoms such as tremors and difficulty in walking, as medication wears off.

Around 1 million people are estimated to have Parkinson's disease in the United States, according to government data.

Abbvie is also developing a similar pump-based treatment to reduce "off episodes", which the FDA also declined to approve last year. It uses a combination of drugs carbidopa and levodopa, which is the standard of care for Parkinson's.

Other treatments for "off" periods include apomorphine, used by Supernus, Acorda's Inbrija, which is levodopa in an inhaled formulation and Kyowa Kirin's Nourianz.

(This April 8 story has been corrected to remove a reference to Sunovion's treatment Kynmobi in paragraph 9)

(Reporting by Puyaan Singh in Bengaluru; Editing by Shinjini Ganguli)