Two New Drugs Approved
FDA Approves Soolantra Cream for Rosacea
Good news for those suffering from Rosacea. Galderma Laboratories’ Soolantra (ivermectin) Cream, 1% has been approved by the FDA for the once-daily topical treatment of the inflammatory lesions, bumps, and pimples of rosacea.
Rosacea is an inflammatory and vascular skin disorder affecting 16 million Americans, many of whom are women 30 years of age and older. Although the cause of rosacea is unknown, studies suggest that factors such as sun, alcohol, spicy food, and exercise can trigger the inflammation associated with the condition. Additional research has also indicated that rosacea may be connected with microscopic Demodex mites, which have been found to be more common on the faces of rosacea patients.
“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” said Linda Stein Gold, M.D., Galderma consultant. “While some rosacea treatments for the common bumps and pimples of the condition may take more than 4 weeks to show effect, Soolantra Cream may provide initial results as early as week 2.” Long-term extensions to the 12-week studies also found that Soolantra Cream was safe and well-tolerated for an additional 40 weeks (52 weeks total), a promising result for rosacea patients with sensitive skin. Some study participants reported skin burning sensation and skin irritation while using Soolantra Cream.
FDA Approves Drug for Children’s Nasal Symptoms Related to Allergic Rhinitis
A new FDA approval may soon help children with allergies seek relief from nasal symptoms. Teva’s beclomethasone dipropionate (Qnasl) 40 mcg has been approved by the FDA for treating nasal symptoms associated with allergic rhinitis (AR) among children 4 to 11 years old, according to the manufacturer’s press release.
Qnasl 40 mcg offers a lower dose formulation than the already-available Qnasl Nasal Aerosol 80 mcg, which is a waterless intranasal corticosteroid spray for individuals 12 and older with nasal problems related to AR. This approval makes Qnasl 40 mcg the only waterless hydrofluoroalkane nasal allergy treatment for children as young as 4 years old, according to Teva.
A study of Qnasl’s efficacy showed that once-daily treatment with 40 mcg of the drug provided greater nasal allergy symptom relief among children with seasonal AR and perennial AR when compared with placebo. Some common side effects were nosebleeds and ulcers.
“The approval of Qnasl for use in children aged 4 to 11 is an important advancement for an often difficult-to-treat patient group,” said Todd Mahr, MD, director of pediatric allergy and immunology at Gundersen Lutheran Medical Center in La Crosse, Wisconsin, in a press release. “Qnasl 40 mcg has several characteristics that provide prescribers with a treatment option specifically designed for children with allergic rhinitis, including its ‘waterless’ aerosol method of delivery and lower dose formulation.” Teva estimates Qnasl 40 mcg will be available by prescription in February 2015.
Source: Pharmacy Times
