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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.
