Innovative Device-Assisted Therapy for Advanced Parkinson’s Disease
For people living with advanced Parkinson’s disease (APD), Intrance’s novel approach has the potential to become a new standard of care allowing for continuous use and optimized treatment for the debilitating symptoms associated with late-stage disease.
As submitted in its IND, Intrance’s proposed treatment approach, known as Lecigon® in Europe, combines a proprietary pharmaceutical gel formulation of a fixed-dose combination of carbidopa, entacapone and levodopa with a wearable, lightweight infusion pump that delivers the drug directly to the small intestine allowing for continuous use in patients with APD.
Lecigon’s Unique Drug Formulation
In the treatment of APD, our proprietary triple-drug gel combination consists of the most widely used active substances: carbidopa, entacapone and levodopa. Levodopa is a precursor of dopamine and mediates the anti-Parkinsonian effect, whereas carbidopa and entacapone modify the metabolism of levodopa to increase and prolong brain exposure to levodopa and to decrease dopamine-related side effects outside the brain. The addition of entacapone to the formulation is unique and increases the bioavailability of levodopa, thereby allowing for lower doses and volumes of levodopa and carbidopa. The lower doses of levodopa and carbidopa enables the use of a smaller container and pump system, but also addresses clinical concerns about potential side effects of high levodopa and carbidopa doses.
Lecigon’s Novel Drug-Device Technology
Utilizing a state-of-the-art technology with a specially designed pump system, our proposed device-assisted therapy provides an accurate, continuous intestinal administration of its triple-drug combination enabling a dosage within the narrowing therapeutic window in APD. The device delivers treatment directly into the small intestine, bypassing the stomach to avoid gastrointestinal dysfunction with erratic gastric emptying as well as overcoming the limitation of levodopa’s short plasma half-life.
Senek, M., Nielsen, E.I. and Nyholm, D. (2017), Levodopa-entacapone-carbidopa intestinal gel in Parkinson's disease: A randomized crossover study. Mov Disord., 32: 283-286. https://doi.org/10.1002/mds.26855