Archive for the 'Nerve Injuries' Category

FDA nod to UCB’s Vimpat as an add-on therapy for epilepsy

The U.S. Food and Drug Administration has given the approval to UCB’s Vimpat® (lacosamide) for use as an adjunct therapy in the treatment of partial-onset seizures in epilepsy patients older than 17 years of age. The novel anti-epileptic drug has an innovative mechanism of action which involves the modulation of activity of sodium channels in the nervous system. It prolongs the long-lasting resting condition of the channel, thereby controlling the hyperactive nerve cells.

European commission grants Cethrin orphan drug designation

The European Commission has granted orphan drug designation to Cethrin developed by Alseres Pharmaceuticals, Inc., for the treatment of traumatic spinal cord injury (SCI). The drug had received the same status from FDA in 2005. Currently being tested for restoration of sensory and motor function, Cethrin is in Phase-II of its clinical trial.
The designation provides the drug with market exclusivity for a period of 10 years in the EU (7 years in the U.S). The Commission considered SCI as one of the rare and critical conditions lacking effective therapies.

FDA approves ThermoSuit(R) System for clinical study

The U.S. Food and Drug Administration has approved Life Recovery Systems‘ ThermoSuit(R) System, a rapid patient cooling device for use in a clinical study of patients suffering from traumatic brain injury. Till now, the system has been in use to induce rapid cooling of heart patients only.The study which will be conducted at the University of Texas Health Science Center in Houston will investigate whether the induction of hypothermia will result in higher number of patients coming up with good outcomes at six months and 12 months after injury as compared to patients who were randomized to normothermia.


JV formed to develop treatment for peripheral nerve injury

Neuron
Cyberkinetics Neurotechnology Systems and NeuroMetrix have come together in a 50:50 joint venture, Peripheral Nerve Injury Repair LLC, for the development and commercial launch of a medical product to treat peripheral nerve injury. The product will be based on Cyberkinetics’ Andara Oscillating Field Stimulator (OFS) neurostimulation technology platform. The companies estimate that up to 100,000 people with laceration, stretch and compression injuries may benefit from nerve fiber growth repair treatment using Andara(TM) OFS(TM) Therapy.