Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch. Continuous subcutaneous apomorphine infusion already has a proven and established 30-year history in Europe , where it has helped deliver more ...

3 days ago · The FDA has approved Supernus Pharmaceuticals’ Onapgo (apomorphine hydrochloride) injection, the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease (PD). According to the company, Onapgo will offer continuous drug delivery via a small wearable device, providing an ...

Feb 4, 2025 · Long road to Onapgo’s approval. Despite these demonstrated benefits, Supernus has faced challenges in getting the therapy approved by the FDA. The company first applied for SPN-830’s approval in 2020, but regulators said the application lacked sufficient data for review.

6 days ago · Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.

5 days ago · The US Food and Drug Administration (FDA) has approved Supernus Pharmaceuticals’ Onapgo (apomorphine hydrochloride) injection to treat motor fluctuations in adults with advanced Parkinson’s disease (PD). ... Onapgo, which is expected to be available in the second quarter of 2025, is a wearable subcutaneous infusion device that provides ...

6 days ago · Supernus Pharmaceuticals, Inc. ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.

6 days ago · 1 ONAPGO. Package insert. Supernus Pharmaceuticals, Inc. *Efficacy results from the analysis of data from the TOLEDO study using the FDA’s preferred methodology, mixed-effects model for repeated ...

4 days ago · THURSDAY, Feb. 6, 2025 -- The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in patients with advanced Parkinson disease, according to a news release from Supernus Pharmaceuticals. Onapgo is the ...

Feb 4, 2025 · Nearly 4 and a half years since its original submission, the FDA has approved Supernus Pharmaceuticals’ investigational agent SPN-830 (Onapgo) as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD).

Feb 4, 2025 · Onapgo is a wearable pump designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). ... Supernus’ Apokyn contributed $19.9 million to the company’s total ...