Great progress in epilepsy! The first nasal spray for the treatment of acute recurrent drug Valtoco (diazepam nasal spray) was approved by the US FDA.

January 18, 2020 / BIOON / -- neurelis is a specialized drug manufacturer headquartered in San Diego, USA, which focuses on authorizing, developing and commercializing drugs for the treatment of epilepsy and other central nervous system (CNS) diseases Recently, the company announced that the US Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) as an acute treatment for intermittent and stereotyped epilepsy with frequent seizures (epilepsy cluster episodes and acute recurrent seizures) in patients aged 6 and over This attack is different from the usual pattern of epileptic seizures in patients Valtoco's unique formulation incorporates intraavail technology for consistent and reliable absorption and has been proven to be generally safe and well tolerated It is worth mentioning that Valtoco is the first nasal spray approved by FDA for epilepsy patients aged 6 and over Valtoco has also been granted a seven-year orphan drug franchise by the FDA orphan product development office Until recently, approved regimens outside the medical establishment had been administered as rectal only Therefore, FDA's approval of Valtoco nasal spray is a major improvement in the community of epilepsy Cluster or acute recurrent seizures are both dangerous and destructive in the lives of epileptic patients Valtoco will provide a safe, reliable, simple and simple nasal spray for these patients Valtoco is a patented diazepam that incorporates a unique combination of vitamin E-based solutions and intraavail ® absorption enhancement technology Previously, the FDA has granted valtoco orphan status and fast track status Intraavail ® mucosal absorption enhancement technology can deliver a variety of proteins, peptides and small molecule drugs noninvasively It is estimated that there are more than 3.4 million epileptics in the United States, and about 200000 new cases are diagnosed every year Although there are chronic daily oral drugs to control epilepsy, a considerable number of patients continue to experience seizures In these uncontrolled patients, about 170000 patients have the risk of frequent attack, also known as cluster or acute recurrent attack This is a major unmet need in epileptic population Valtoco's approval is supported by data from a wide range of clinical and preclinical studies, including in healthy volunteers and epileptics The safety of valtoco was evaluated in a long-term, open label, repeat dose study in which more than 130 patients were enrolled and more than 2000 seizures were treated with valtoco In the study, valtoco showed high bioavailability, low variation between each administration, good safety and tolerance, and the most common adverse reactions (≥ 4%) were drowsiness, headache and nasal discomfort Craig Chambliss, President and CEO of neurelis, said: "the treatment of cluster or acute recurrent epilepsy is very challenging and highly destructive to the life of epileptics Valtoco is developed to provide an effective combination of reliability, safety and tolerance in a nasal spray This approval is a decisive moment for neurelis because valtoco is our first FDA approved product We are very pleased that we are now able to provide this treatment program for patients and additional support for the epilepsy community " Dr R Edward Hogan, director of the University of Washington and the Jewish epilepsy center in St Louis Barnes, said: "this approval is significant news for the epilepsy community At present, most epilepsy that need to be intervened are treated in an inconvenient way Options such as valtoco, which allow caregivers to reliably treat seizures at any time and place, are a major step forward The launch of valtoco will have a positive impact on the lives of thousands of epileptics and their care partners who have experienced cluster or acute recurrent seizures " Source of original text: neurelis anonces FDA approve for seizure rescue treatment valtoco ® (diazepam nasal spray) the enterprises the science of interval ® for constraint and disable prohibition