New medicines for Parkinson’s may be around the corner. The United States Food and Drug Administration (US FDA) recently approved one drug, and accepted application another. Both new drugs treat movement related symptoms. Keep reading to learn more about each new possibility, or follow the original stories here, and here.
The FDA approved a drug known as Osmolex. Osmolex ER (amantadine, extended release) aims to treat Parkinson’s disease and therapy-induced extrapyramidal reactions. This includes both the movement-related issues and muscle control difficulties that are so common with Parkinson’s. Such symptoms can also be the side effects of other medications.
Osmolex ER comes as a once daily tablet and is produced by Osmotica Pharmaceutical. What stands out the most to this author, is that it makes dosing simpler, which could improve instances of patients taking treatment as prescribed.
Taken in the morning, Osmolex ER utilizes a controlled release for the rest of the day. The drug also comes in three dosages to allow physicians to prescribe as needed up to the maximum of 322 mg per day.
Other Parkinson’s disease development news comes from Acorda Therapeutics. The FDA accepted an application from Acorda for their new drug Inbrija (CVT-301). After accepting an application, the FDA begins an intensive review of the drug to ensure it meets regulations and requirements. The FDA expects to decide whether or not to approve Inbrija by October 5th of this year.
While Osmolex will be available as a tablet, Inbrija will be distributed as an inhalant. Effectively, Inbrija is a powdered variation of levopoda designed to be effective when inhaled. Developers claim its intended use is as a treatment for when a Parkinson’s patient experiences off periods. In other words, Inbrija functions as a type of patch when there are gaps in the effectiveness of other medications.
Acorda’s new drug application also includes results from a 12-week Phase 3 clinical trial (click here for more details) including 351 patients. One of the major findings indicates that with a higher dose of Inbrija, taken up to five times per day, there is improved mobility for patients during off periods in comparison to treatment with a placebo.
Discussing Inbrija, Dr Todd Sherer (CEO, The Michael J. Fox Foundation) underscored how “inhaled delivery of levodopa could help the many people living with Parkinson’s facing the complication of off periods as their disease progresses.”
Though not speaking directly about Osmolex, Dr. Sherer also commented that both physicians and patients need more flexibility when it comes to managing Pakrinson’s. People need more choices when facing this disease.