MediciNova begins enrolment in opioid abuse MN-166 Phase IIa trial

20th November 2012 (Last Updated November 20th, 2012 18:30)

Biopharmaceutical company MediciNova has begun enrolment in Phase IIa trial of MN-166 (ibudilast) in opioid abusers.

Biopharmaceutical company MediciNova has begun enrolment in Phase IIa trial of MN-166 (ibudilast) in opioid abusers.

The trial, funded by the National Institutes for Drug Abuse (NIDA), will be conducted at Columbia University and the New York State Psychiatric Institute.

A total of 24 healthy abusers of prescription opioids, such as oxycodone or hydrocodone, or heroin are expected to be enrolled in the study.

Trial primary investigator, Columbia University and the New York State Psychiatric Institute professor of clinical neurobiology Dr Sandra Comer said inclusion of prescription opioids such as OxyContin and Vicodin in the MN-166 investigation will increase the number of people qualifying for the trial.

"We have seen positive signals with MN-166 in our earlier Phase Ib work in heroin addiction and look forward to pursuing this unique therapeutic approach for opioid addiction, a very complex and difficult health condition that can affect anyone and often requires long-term treatment and care," Comer said.

"Inclusion of prescription opioids such as OxyContin and Vicodin in the MN-166 investigation will increase the number of people qualifying for the trial."

The NIDA-supported trial is designed to evaluate MN-166's ability in minimising withdrawal symptoms following opioid detoxification, reducing the tendency to self-administer oxycodone and improving the acute pain relief action of oxycodone.

Subjects will be detoxified and randomised with either placebo or 100mg/day ibudilast (MN-166).

MediciNova president and CEO Dr Yuichi Iwaki said the initiation of this trial builds upon the momentum created through the clinical programme for MN-166 in drug addiction and other neurological disorders.

"MN-166 is a very unique therapeutic that may have the potential to help patients with debilitating disorders who have little to no other options," Iwaki said.

The Phase IIa trial is the second of a strategic set of trials evaluating MN-166's potential in opioid abuse and withdrawal.

Orally bioavailable small molecule glial attenuator is also being evaluated for methamphetamine addiction in a Phase II trial at UCLA and will shortly be assessed for multiple sclerosis in a separate Phase II trial.