Qilu Pharmaceutical Submits NDA for Memantine Hydrochloride Oral Soluble Film for Moderate-to-Severe Alzheimer's Disease

On November 18, the marketing application for Qilu Pharmaceutical’s Class 2.2 new drug, memantine hydrochloride orally disintegrating film, was accepted by the Center for Drug Evaluation (CDE) for the treatment of moderate-to-severe and severe Alzheimer’s-type dementia.

Memantine hydrochloride is a first-line medication recommended by clinical guidelines for the treatment of moderate-to-severe Alzheimer’s disease. It can be administered as monotherapy or in combination with donepezil or rivastigmine. Currently, marketed formulations in China include tablets (included in the volume-based procurement list), oral solution, and extended-release capsules (with Chengdu Yuandong Pharmaceutical becoming the first to pass the consistency evaluation on October 11). Given that patients with this condition often experience difficulties in medication administration and poor adherence, the launch of orally disintegrating films will significantly improve patient compliance.

Qilu Pharmaceutical is the company with the most extensive portfolio of orally disintegrating film formulations in China. Currently, five orally disintegrating film products have been submitted for market approval, as detailed below:

Source: PharmaCube PharmaGo