Positive results have been announced from a phase 3 study of self-administered subcutaneous (SC) abaloparatide (Radius Health, Inc.) for the treatment of postmenopausal women with osteoporosis. The study showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (P < 0.001) and nonvertebral fractures (P = 0.049) compared with placebo.
The results were published in the Journal of the American Medical Association.
The Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) was an 18-month, randomized, double-blind, placebo-controlled, international study in 2,463 postmenopausal women with osteoporosis. The study was designed to evaluate the efficacy and safety of an 80-mg SC injection of abaloparatide in reducing the risk of vertebral and nonvertebral fractures.
Abaloparatide is a synthetic peptide that engages the parathyroid hormone 1 (PTH1) receptor. It was designed for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for fractures.
Self-administered SC abaloparatide has completed phase 3 development for potential daily use. Radius submitted a new drug application (NDA) for SC abaloparatide to the FDA at the end of the first quarter of 2016. The NDA was accepted for filing with a Prescription Drug User Fee Act (PDUFA) goal date of March 30, 2017. Radius is also developing a transdermal formulation of abaloparatide based on patented Microstructured Transdermal System (3M Company) technology for potential use as a treatment for osteoporosis.
An estimated two million osteoporotic fractures occur annually in the U.S., and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation has estimated that 10 million people in the United States––eight million women and two million men––have osteoporosis, and that approximately 44 million more people have low bone mass that places them at increased risk for osteoporosis.
Source: Radius; August 16, 2016.