The Food and Drug Administration (FDA) has approved Lundbeck’s Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine, and Lundbeck plans to make it commercially available in the US in early 2017. Carnexiv is a short-term (7 days) intravenous replacement therapy for oral carbamazepine formulations that provides continuity of care for adult patients who are unable to take carbamazepine by mouth and have seizure types: partial seizures with complex symptomatology; generalized tonic-clonic seizures; and mixed seizure patterns.
Chicago, IL – This month the Drug Enforcement Administration (DEA) announced their decision to maintain marijuana as a Schedule I drug, despite petitions from Citizens United for Research in Epilepsy (CURE) and many other research and patient-focused organizations concerned with the federal barriers prohibiting researchers from fully understanding the potential of medical cannabis. Despite this setback, CURE is pleased with the DEA’s decision to expand the number of DEA-registered marijuana manufacturers for research, of which there is currently only one, so more researchers will be able to conduct much-needed research on cannabidiol (CBD) – the major non-psychoactive ingredient in marijuana, as well as the many other cannabinoids found in marijuana.
An estimated 3 million Americans currently live with epilepsy and for two-thirds of them, the cause is unknown, making treatment difficult if not impossible to pinpoint. The positive results that some people with epilepsy have been seeing from CBD-rich marijuana extracts are giving so many parents what they have been lacking for so long – hope. CBD may not be the answer for all of these families, but when available medications and surgeries do not stop the uncontrollable seizures, every avenue must be explored.
As the leading nongovernmental agency fully committed to funding research in epilepsy, we believe researchers should be encouraged and supported to test not only pure CBD, but also high CBD/low-THC cannabis, pure-THC and other types of medical marijuana to determine the efficacy of these and other combinations on seizure control and the genesis of epilepsy. We are hoping for more changes to marijuana access that makes it easier for researchers to continue their vital work.
WASHINGTON, D.C.— Due to its incredible medicinal potential, we continue to believe that more research must be done on marijuana rich in cannabidiol (CBD). In late April, CURE signed a group letter addressed to Chuck Rosenberg, the head of the Drug Enforcement Administration (DEA), urging him to remove cannabis from Schedule I in the Controlled Substances Act.
This would eradicate federal barriers to research, paving the way for more progressive research and new treatments. CURE has joined with other organizations in support of the Compassionate Access, Research Expansion, and Respect States Act (CARERS, S. 683, H.R. 1538) which would facilitate safe and legal access to medical cannabis for patients and physicians acting in accordance with state law and lift federal barriers to research. The CARERS Act would also remove low-THC cannabis from the CSA allowing individuals in states that have created protections for low-THC therapies to more easily access this potential treatment option.
Current regulatory hurdles make it difficult for researchers to gain access to marijuana rich in CBD. There is no debate that the hoops through which researchers must jump to acquire marijuana, or any chemical found in it, are hindering scientific advancement—and CURE is committed to helping researchers overcome these obstacles to advance research in this important area.
WASHINGTON, D.C.— Acorda Therapeutics, Inc. announced May 20 it will discontinue development of PLUMIAZ™ (diazepam) Nasal Spray, an investigational therapy which was being studied for the treatment of seizure clusters in people with epilepsy. Data from ongoing clinical trials do not demonstrate its bioequivalence to Diastat® gel, which is needed for New Drug Applications (NDA).
GW Pharmaceutical’s big announcement in March regarding the investigation of a purified, formulated, potential cannabinoid CBD medication not only caused its stock price to surge, but also spoke to a potential breakthrough in CBD access for children with epilepsy.
Article, published in Epilepsia
People with epilepsy (PWEs) are often advised against participating in sports and exercise, mostly because of fear, overprotection, and ignorance about the specific benefits and risks associated with such activities. Available evidence suggests that physical exercise and active participation in sports may favorably affect seizure control, in addition to producing broader health and psychosocial benefits. This consensus paper prepared by the International League Against Epilepsy (ILAE) Task Force on Sports and Epilepsy offers general guidance concerning participation of PWEs in sport activities, and provides suggestions on the issuance of medical fitness certificates related to involvement in different sports. Sports are divided into three categories based on potential risk of injury or death should a seizure occur: group 1, sports with no significant additional risk; group 2, sports with moderate risk to PWEs, but no risk to bystanders; and group 3, sports with major risk. Factors to be considered when advising whether a PWE can participate in specific activities include the type of sport, the probability of a seizure occurring, the type and severity of the seizures, seizure precipitating factors, the usual timing of seizure occurrence, and the person’s attitude in accepting some level of risk. The Task Force on Sports and Epilepsy considers this document as a work in progress to be updated as additional data become available.