NP2 treats chronic pain with Enkephalin
The NP2 NTDDS product, for which Diamyd Medical initiated a Phase I trial in 2008, is a treatment where chronic pain is treated with Enkephalin, one of the body's natural opioid peptides. Preclinical trial results demonstrate that NP2 effectively relieves pain for weeks to months following a single dose. The treatment can be administered multiple times without the patient becoming addicted or developing tolerance. The treatment has also been shown to be safe, and does not cause side effects, unlike traditional pain treatment. In addition, NP2 may be combined with morphine to provide synergistic therapeutic effects.
The Phase I study is being conducted at the University of Michigan in the US, with the objective of testing the safety of the treatment. The study is an open label, dose escalating trial design that includes 12 to 24 patients suffering from severe cancer pain. The study constitutes a safety study for the entire NTDDS platform, and forms the foundation for future studies of other substances and diseases. The study also includes measures of efficacy by monitoring the patient's pain level and use of concurrent pain medications.
Preclinical trials have also shown that the NTDDS Enkephalin approach effectively relieves diabetic neuropathic pain in animals. The animal study results indicate that the treatment is not only effective in reducing pain, but may also alter the pathway leading to pain, thus potentially representing a reversal of the syndrome.