New Way to Administer Spasticity-Preventing Drug Reaches Clinical Trials

For people who have medical issues like cerebral palsy, multiple sclerosis, and brain and spinal cord injuries, spasticity and involuntary muscle contractions are common. An existing muscle relaxant called baclofen helps to reduce these spams if taken routinely—but sometimes therapy is abruptly interrupted, which can result in serious adverse effects.

A new method of administering baclofen, developed by University of Minnesota researchers, stands to help safely control muscle spasms when patients are unable to take their medicine by mouth. The treatment, which is injected into the veins (intravenously), was developed by Linda Krach, MD, physical medicine and rehabilitation physician, Gillette Children’s Specialty Healthcare and a Medical School adjunct professor of rehabilitation medicine, along with College of Pharmacy Department of Experimental and Clinical Pharmacology researchers Robert Kriel, MD, adjunct professor, and James Cloyd, PharmD, Morse Alumni Distinguished Teaching Professor.

The idea for an intravenous baclofen injection came about when the research team recognized a problem with the two existing, FDA-approved versions of the drug: a tablet taken by mouth and an injection delivered directly to the spinal fluid. Patients using either therapy can experience serious and even life-threatening complications if the treatment is suddenly interrupted. Interruption of therapy can cause severe withdrawal symptoms.

“There are currently no effective therapies on the market to prevent or manage the withdrawal syndrome,” Cloyd said. “The intravenous baclofen formulation is intended as a bridging therapy for patients whose oral baclofen therapy has been abruptly interrupted. It will allow clinicians to precisely replace the amount of oral baclofen a patient was taking, maintaining the blood levels needed to control spasticity.”

With help from U of M Technology Commercialization, the team licensed the intravenous delivery method to New Jersey-based pharmaceutical company Allaysis, which now has completed a clinical study, done in collaboration with the UMN team, and received a patent on the specific drug formulation that will aid in its clinical development and marketing.

A new drug application will soon be submitted to the US Food and Drug Administration, which could approve the intravenous formulation by the end of 2020. The therapy is moving toward the market and to the patients that could benefit from it—faster than many new drug treatments, Cloyd noted, because of earlier animal and human research done by the U of M team and the fact that it is a formulation of a drug that already exists as an approved therapy.