Valeant Pharmaceuticals International has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for Cesamet (CII) (nabilone) oral capsules for the treatment of cancer chemotherapy-induced neuropathic pain.

Cesamet, a synthetic cannabinoid, was launched by Valeant in the United States in 2006 for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Cesamet was recently approved in Mexico for the treatment of chemotherapy-induced nausea and vomiting and pain, a Valeant press release stated.

"The filing of our IND is a significant milestone in the development of Cesamet. There are more than 150,000 new cases of chemotherapy-induced neuropathic pain per year in the United States, with no current approved therapy for these patients. The development of a new agent to control chemotherapy-induced neuropathic pain would fulfill a significant unmet need for patients and physicians to treat the symptoms from chemotherapy-induced neuropathic pain," said Wes Wheeler, President, Valeant North America/Research and Development.

"It is exciting that Valeant is initiating this trial to determine whether Cesamet's unique effect on cannabinoid receptors found throughout the body could play a role in treating chemotherapy-induced neuropathic pain," said Joseph Pergolizzi, M.D., adjunct assistant professor, Johns Hopkins University School of Medicine. "Cesamet has proven to be an effective tool for those who have not responded well to conventional antiemetic treatment for chemotherapy-induced nausea and vomiting."

A report from the Institute of Medicine (IOM) regarding the treatment of chronic pain concluded that a cannabinoid could potentially be useful for chemotherapy patients and those with peripheral neuropathic pain. In its report, the IOM also noted that clinical studies of cannabinoids should be prioritized.

Although there are currently no approved treatments for chemotherapy-induced neuropathic pain, treatments for other types of neuropathy include opioids, tricyclic antidepressants, GABA analogs and nonsteroidal anti-inflammatory drugs. According to an article in the journal PAIN, the treatment of neuropathic pain is still difficult despite new therapies, and there is no single therapy that works for all conditions and their underlying mechanisms.