FDA Approves Supernus’ Onapgo for Advanced Parkinson’s Treatment

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).

Almost one million people in the US are living with PD, a progressive neurodegenerative disorder that can cause tremors, muscle rigidity, involuntary movements, and difficulty with movement and balance.

Patients report switching from an ‘on’ state, when their motor symptoms are generally well controlled with treatment, to an ‘off’ state, when their symptoms return.

Onapgo, which is expected to be available in the second quarter of 2025, is a wearable subcutaneous infusion device that provides continuous treatment with the dopamine agonist apomorphine to help reduce ‘off’ time.

Because Onapgo is delivered subcutaneously, the drug bypasses the gastrointestinal tract and directly enters the brain, potentially leading to more predictable symptom improvement.

The FDA’s decision was supported by positive results from a late-stage trial showing that Onapgo significantly reduced the amount of daily ‘off’ time at 12 weeks from baseline, with Onapgo-treated patients experiencing a 2.6-hour reduction compared to 0.9 hours for placebo.

A similar increase in daily good ‘on’ time was observed, at 2.8 hours for patients randomised to receive Onapgo compared to 1.1 hours for the placebo group, and Onapgo-treated patients also more frequently reported improvements in their general health compared to those in the placebo cohort.

Clinical trial investigator Rajesh Pahwa, the University of Kansas, said: “Continuous subcutaneous apomorphine infusion already has a proven and established 30-year history in Europe, where it has helped deliver more consistent control of motor fluctuations for thousands of patients.

“[This] approval of Onapgo means patients in the US who are not responding well to their current treatment regimen… will now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure.”

The authorisation comes just over three months after the FDA approved AbbVie’s continuous PD therapy Vyalev, a solution of foscarbidopa and foslevodopa, to treat motor fluctuations in adults with advanced stages of the disease.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!