Delayed-release GERD medication approved
The FDA has approved dexlansoprazole (Kapidex) delayed- release capsules (30 and 60 mg) for the once-daily oral treatment of heartburn associated with symptomatic, nonerosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE), and the maintenance of healed EE. Dexlansoprazole is a product of Takeda Pharmaceuticals. The drug is the first proton pump inhibitor (PPI) with a dual-delayed release formulation designed to provide two separate releases of medication.
Approval was based on data from studies conducted in 20 countries evaluating approximately 6,000 patients with erosive and nonerosive GERD. Dexlansoprazole contains two types of enteric-coated granules resulting in a concentration time profile with two distinct peaks. The first occurs 1 to 2 hours after taking the medication, and the second occurs within 4 to 5 hours. Dexlansoprazole can be taken without regard to the time food is consumed.
The most common adverse reactions associated with dexlansoprazole treatment in clinical trials were diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. Consult product labeling for further prescribing information.
New acne gel combines treatments
The FDA has approved Epiduo, a new prescription acne gel for use in patients 12 years of age and over. The once-daily medication combines two established acne treatments: adapalene 0.1% and benzoyl peroxide 2.5%. According to the manufacturer, Galderma, Epiduo treats both inflammatory and noninflammatory lesions with no evidence of promoting antibiotic resistance. Studies show that Epiduo is more efficacious than either of its components used alone, and significantly reduces total acne lesions by approximately 18% as early as the first week of treatment.
The most common adverse reactions associated with Epiduo are redness, scaling, dryness, stinging, and burning.
Vitamin D formulation treats plaque psoriasis
Galderma Laboratories has received FDA approval of calcitriol ointment (Vectical) 3 mcg/gram, a unique vitamin D3 product for the treatment of mild to moderate plaque psoriasis in adults.
Vectical is the only vitamin D3 ointment of its kind available in the United States. The ointment contains calcitriol, the naturally occurring active form of vitamin D3, and is one of the only vitamin D3 products shown in clinical trials to be well tolerated even when used on sensitive skin-fold areas, according to Galderma.
Approval was based on two 8-week studies of more than 800 patients that compared twice daily doses of Vectical with a vehicle treatment. In the first study, improvements in mild to moderate plaque psoriasis were seen in week 2, and treatment effects were sustained over 8 weeks. By the end of the study, 34% of patients achieved treatment success compared with 22% of those treated with placebo. Twenty-three percent of patients showed success at 8 weeks and also showed a two-grade improvement in disease severity. The second study showed similar efficacy results.
Treatment-related adverse reactions were similar for both the treatment and placebo groups. Consult product labeling for further prescribing information.
ER formulation manages chronic pain
The FDA has approved marketing of an extended-release (ER) once-daily formulation of trama dol (Ryzolt) for the management of moderate to moderately severe chronic pain. The new formulation of tramadol uses Labopharm's proprietary controlled-release technology (Contramid) for oral administration of existing solid-dosage medications.
The controlled-release formulation of tramadol is composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics. The product will be available in 100 mg, 200 mg, and 300 mg formulations later this year.