Flowonix Medical and Cerebral Therapeutics said today that the 1st patients were implanted with the Prometra II programmable infusion system in a clinical trial evaluating the pump in patients with refractory epilepsy. The Address trial marks the 1st time a programmable, implantable pump has been used to deliver medication, in this case valproate, directly to the brain.
The Prometra micro-infusion device controls drug delivery to a region of the brain associated with medically refractory epilepsy.
The trial is slated to enroll 9 patients, who will receive intracerebroventricular administration of valproate using Flowonix’s programmable pump.
“We are really excited to be able to study this new treatment option for patients in the Address trial – it may offer new hope to those with uncontrolled epilepsy,” Mark Cook, chair of medicine & director of neurosciences at St. Vincent’s Hospital, said in prepared remarks.
Patients with refractory epilepsy do not respond to traditional medications and have higher mortality and a diminished quality of life compared to patients whose epilepsy is adequately controlled with drugs. Nearly 1 in 3 people with epilepsy develop refractory epilepsy, the companies said.
“The ability to target-deliver anti-epilepsy medication through an established infusion pump delivery could be a treatment with profoundly positive ramifications,” Dr. Ashwini Sharan, president of the North American Neuromodulation Society, said. “This is the 1st time in the world this approach is being taken.”
The Prometra device is FDA-approved for the intrathecal infusion of Infumorph, a perservative-free morphine sulfate sterile solution, or preservative-free sterile 0.9% saline solution.
“Neurological disorders can be devastating to patients and their families, who are often left with few options,” Flowonix CEO Larry Heaton said. “Flowonix is emerging as a world leader in implantable drug infusion systems used to treat pain, and we have particular expertise in the accurate and reliable delivery of microdoses of medication.”
“As the 1st trial of its kind, the Address study is a significant milestone for Flowonix Medical, Inc., Cerebral Therapeutics, the healthcare community, and patients worldwide. If the clinical study results in demonstrated positive outcomes, it would benefit patients who have refractory epilepsy and establish targeted drug delivery directly to the brain. It is gratifying when technological advancements offer such exciting possibilities for a new group of patients in need.”