BOT - Anything but charting, page-5725

Ecclock has been used in JAPAN in ALS and Parkinson’s disease to limit hypersalivation safely and effectively.

THE TAM potentially is expanding as are use cases for SB.

DYOR



Sofpironium bromide gel

Patients with intractable neurological diseases, such as amyotrophic lateral sclerosis (ALS) and Parkinson's disease, experience hypersalivation similar to patients receiving clozapine therapy.^{Reference Isaacson, Ondo, Jackson, Trosch, Molho and Pagan28} An external anticholinergic preparation, 5% scopolamine ointment, has been used to treat them. Although this drug is not commercially available, the use of such a drug is recommended to treat drooling in Japanese guidelines for ALS (N = 30 patients; the difference in the efficacy between drug and placebo groups was over approximately 30%).^{29,Reference Mato, Limeres, Tomás, Muñoz, Abuín and Feijoo30} Therefore, in 2020, insurance coverage was approved in Japan for sofpironium bromide gel (5% ECCLOCK® gel), an external preparation of an anticholinergic drug with M1–5 muscarinic receptor antagonistic action against primary axillary hyperhidrosis.^{Reference Yokozeki, Fujimoto, Abe, Igarashi, Ishikoh and Omi23} In the Japanese phase 3 trial (patients who received sofpironium bromide gel (141 patients) or placebo (140 patients)), in addition to the efficacy (the difference was 17.5% between two groups), the incidence of constipation caused by sofpironium bromide gel was extremely low (0.7%). The main adverse events were limited to localised skin reactions such as dermatitis and erythema, making this preparation extremely useful in clinical settings.^{Reference Yokozeki, Fujimoto, Abe, Igarashi, Ishikoh and Omi23} As a derivative of glycopyrronium, sofpironium bromide consists of a chemically modified structure that allows the drug to undergo rapid hydrolytic deactivation, and thus minimise the significant side-effects associated with traditional anticholinergic drugs. Furthermore, the retrometabolic drug design of topical sofpironium bromide presents distinct advantages by limiting systemic absorption and therefore development of anticholinergic adverse events. Therefore, local external administration of anticholinergic drugs can reduce systemic side-effects compared with oral administration or injection of anticholinergic drugs.