Merck Says Odanacatib Meets Primary Endpoints Phase 3 Fracture Outcomes Study

(RTTNews) - Merck & Co. Inc. (MRK) on Monday announced data from the pivotal Phase 3 fracture outcomes study for odanacatib, the company's investigational once-weekly cathepsin K inhibitor, in postmenopausal women with osteoporosis.

In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo, the company said.

In addition, treatment with odanacatib led to progressive increases over five years in bone mineral density at the lumbar spine and total hip.

The rates of adverse events overall in the trial were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.

Merck said it continues to collect data from the blinded extension study and is planning additional analyses of data from the trial, including an independent re-adjudication of major adverse cardiovascular events, in support of regulatory submissions.