A Swedish company’s combination gel and pump delivery system, Lecigon, has received regulatory approval for the treatment of patients with advanced Parkinson’s disease.
The gel formulation of LobSor Pharmaceuticals AB’s Lecigon, manufactured and supplied by contract manufacturing organisation Recipharm, is made up of levodopa/carbidopa and entacopone, which is continuously infused into the small intestine via a lightweight pump.
“The Lecigon system requires a surgical procedure to insert a tube through the abdomen wall to get access to the small intestine, where the uptake is,” company chairman Ulf Rosén explained.
The system is intended for patients who are inadequately controlled by oral medication – and for these patients, Lecigon can improve convenience and quality of life, he added.
According to Rosén, the company is also looking to market the drug in other geographies: “Marketing authorization has been obtained in Sweden, as the first country. However, the ambition is to expand to the other Nordic countries and key European markets as soon possible.”
A Sinemet alternative?
The announcement comes as health authorities prepare for a global shortage of Parkinson’s disease oral solid dose medicine, Sinemet.
According to marketing authorisation holder, MSD (known as Merck & Co. in North America), production constraints at a contract manufacturer’s facility are responsible for Sinemet’s low supply – which is expected to continue through to spring of next year.
However, Lecigon may not be a suitable alternative for all Parkinson’s patients affected by the shortage, we were told.
Lecigon requires invasive surgery, and the patient must be placed under professional observation during the dose titration phase, explained Rosén.
“To go through this procedure to bridge a supply shortage of Sinemet sounds a bit farfetched. Patients who do so would normally expect to be on an invasive treatment for several years, potentially lifelong.
“Having said that and if the doctor/patient decide to go through all of the above, Lecigon would probably work very well after proper titration. In that case it is probably not the shortage of Sinemet, but the need for a change of therapy that would trigger the prescription of Lecigon,” he added.
https://www.in-pharmatechnologist.com/Article/2018/10/10/Recipharm-made-Parkinson-s-treatment-approved-in-Sweden
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