A brand new Supernus Prescribed drugs medical system that repeatedly administers an outdated Parkinson’s illness drug is now FDA accepted, giving sufferers one other option to handle the motor management signs that return when the results of normal remedy for the neurological illness wanes.
The drug/system mixture product, identified in improvement as SPN-830, might be commercialized below the model title Onapgo. Supernus mentioned Tuesday it plans to launch Onapgo within the second quarter of this yr. The Rockville, Maryland-based firm, which focuses on therapies for central nervous system illnesses, has not but disclosed pricing for its latest product.
The spine of Parkinson’s remedy is levodopa, a compound that’s transformed to dopamine within the mind to spice up ranges of this mind chemical that sufferers lack. The durations when this treatment works are known as “on” instances. However Parkinson’s sufferers additionally expertise “off” instances when levodopa remedy wears off and motor signs return. One remedy choice for these off durations is a special drug, apomorphine.
Apomorphine mimics dopamine, binding to receptors liable for motor management. An FDA-approved injectable model of this drug has been out there for greater than 20 years for treating the off episodes of Parkinson’s. In 2020, Sunovion Prescribed drugs’ sublingual movie formulation of apomorphine obtained FDA approval for intermittent remedy of the off episodes of Parkinson’s.
Supernus already has a presence in Parkinson’s. Its second-largest product by income is Gocovri, a capsule that treats dyskinesia and off time in Parkinson’s sufferers. The corporate additionally already markets apomorphine, dosed as wanted through an injection pen product branded as Apokyn. However motor signs of Parkinson’s worsen because the illness progresses and off durations can occur at any time. Steady infusion of apomorphine gives an extra option to handle these unpredictable off instances.
Supernus sources Apokyn from Britannia Prescribed drugs, a subsidiary of German firm Stada Arzneimittel. Britannia markets each injectable and steady infusion apomorphine merchandise in Europe. A license and provide settlement with Britannia grants Supernus the correct to make use of and market injectable apomorphine within the U.S. The 2016 pact additionally covers the joint improvement of different apomorphine merchandise, together with drug administered as a steady infusion. Supernus should pay Britannia royalties on internet gross sales for merchandise lined by the settlement. Britannia retains rights to its drug exterior of the U.S.
Onapgo, a tool secured to the physique by an elastic band worn across the waist, has had a rocky regulatory journey main as much as its FDA nod. Supernus functions in search of regulatory approval have been turned again by the FDA in 2022 and once more final April, because the company requested for extra details about varied elements of the drug/system mixture product candidate. Final August, the FDA accepted Supernus’s resubmitted software and set a Feb. 1 goal date for a regulatory resolution.
The long-awaited FDA approval relies on the outcomes of a placebo-controlled Part 3 take a look at that evaluated Onapgo for 12 weeks. Outcomes confirmed that sufferers who obtained the Supernus remedy skilled a 2.6-hour discount in every day off time in comparison with 0.9 hours for individuals who obtained a placebo. Sufferers who obtained the Supernus remedy additionally skilled a rise in on time for his or her Parkinson’s drugs — 2.8 hours for the Onapgo arm in comparison with 1.1 hours for the placebo group. The commonest antagonistic occasions reported within the examine included infusion-site reactions, nausea, sleepiness, dyskinesia, headache, and insomnia.
In Supernus’s announcement of the product approval, Dr. Rajesh Pahwa famous the 30-year historical past of steady subcutaneous apomorphine infusions in Europe. Pahwa, a professor of neurology on the College of Kansas College of Drugs, director of the Motion Dysfunction Program at The College of Kansas Well being System, and an investigator for Onapgo’s scientific trial, pointed to the numerous discount in off time and enhance in on time for sufferers handled with the Supernus product.
“As we speak’s approval of Onapgo means sufferers within the U.S. who aren’t responding nicely to their present remedy routine, together with levodopa, will now have the choice of utilizing a small and light-weight wearable system to ship a steady infusion with out the necessity for an invasive surgical process,” Pahwa mentioned.
Picture: Dr_Microbe, through Getty Pictures
