Emisphere's oral salmon calcitonin product addresses persistent musculoskeletal pain

Dec 22 2009

Emisphere Technologies, Inc. (OTC BB: EMIS) today announced a meta-analysis published in the December 2009 edition of Rheumatology Reports examining independent evidence of the analgesic action of the hormone calcitonin. This publication restates the potential of calcitonin in filling a significant unmet need for alternative treatments for persistent musculoskeletal pain.

“An ideal treatment with an optimal efficacy, safety and convenience profile is not available for the musculoskeletal pain associated with such conditions as osteoporosis and osteoarthritis. This review of the literature highlights the clear unmet medical need that could be addressed by Emisphere's oral salmon calcitonin product”

Oral salmon calcitonin, which uses the proprietary absorption enhancing Eligen^® Drug Delivery Technology, is being studied in osteoarthritis and osteoporosis by Novartis Pharma AG and Nordic Bioscience. Scientists from Nordic Bioscience were involved in the preparation of this meta-analysis.

Non-malignant musculoskeletal pain is the most common clinical symptom that causes patients to seek medical attention and is a major cause of disability in the world. Musculoskeletal pain can arise from a variety of common conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, surgery, low back pain and bone fracture.

The meta-analysis, conducted by researchers at the Center for Sensory-Motor Interaction in the Department of Health Science and Technology at Aalborg University in Denmark, examined independent pre-clinical and clinical studies spanning nearly 45 years of the possible intrinsic analgesic properties of calcitonin, with special focus on the challenges in the musculoskeletal system. The authors concluded that well-designed clinical trials should be conducted to further validate evidence of calcitonin’s analgesic action and its promising potential role in the management of musculoskeletal pain.

The effects of calcitonin on clinical pain conditions have received increasing attention in the past decades, although a consensus on mechanism-of-action and potential indications has not been reached. The analgesic activity of oral salmon calcitonin has been shown in several controlled prospective double-blind studies; besides pain management in osteoporosis, calcitonin has shown analgesic action in painful conditions such as phantom limb pain, diabetic neuropathy, complex regional pain syndrome, adhesive capsulitis, rheumatoid arthritis, vertebral crush fractures, spondylitis, tumor metastasis, cancer pain, migraine, Paget’s disease of bone as well as post-operative pain.

“An ideal treatment with an optimal efficacy, safety and convenience profile is not available for the musculoskeletal pain associated with such conditions as osteoporosis and osteoarthritis. This review of the literature highlights the clear unmet medical need that could be addressed by Emisphere's oral salmon calcitonin product,” said Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies.

Emisphere’s Eligen^® Technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity. Eligen^® delivery agents, or “carriers”, facilitate or enable the transport of therapeutic molecules across the mucous membranes of the gastrointestinal tract to reach the tissues of the body where they can exert their intended pharmacological effect.