Drug companies are rare in medical-device crazed Minnesota. Even more rare is a startup that can win approval from the Food and Drug Administration, given the cost and regulatory hurdles of pushing drugs to market, these days.
Gablofen is CNS’ first commercially available product and a welcome relief to Thomas, McNerney & Partners and InterWest Partners, the two venture capital firms bankrolling the three-year-old company. CNS also recently received a $245,000 grant from the federal Qualifying Therapeutic Discovery program.
The drug, which can be administered continuously and directly to the central nervous system via an implanted pump (intrathecal therapy), helps patients with severe spasticity, a movement disorder caused by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma and stroke.
About 500,000 patients in the United States suffer from the incurable disease, the company says.
CNS claims intrathecal therapy is more effective than oral treatments because it can avoid the blood-brain barrier and deliver more of its payload to the target. The company also hopes the same technology can treat other neurological diseases like Parkinson’s disease. The Michael J. Fox Foundation is backing its research.
“When we founded CNS Therapeutics, our goal was to improve on existing intrathecal therapies by addressing the concerns of patients and all caregivers involved in the treatment path,” CEO John Foster said in a statement. “Gablofen marks our first FDA approval and is a significant first step in our company mission to innovate in the areas of spasticity, Parkinson’s disease and chronic, intractable pain.”