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| |  Diastat (Diazepam) Available In Canada As A Rectal Gel For Uncontrolled Seizures MISSISSAUGA, ON -- February 21, 2000 -- Draxis Health Inc. announced the introduction of its unique epilepsy drug Diastat(R) in pharmacies across Canada. Diastat (diazepam rectal gel) is used to treat children and adults with uncontrolled epileptic seizure clusters known as Acute Repetitive Seizures (ARS). While intravenous diazepam is the most common antiepileptic medicine used in emergency rooms for treating seizures, it can only be administered by a healthcare professional at the hospital. For a condition where every minute counts, Diastat allows caregivers (parents, family members, etc.) to treat uncontrolled seizures immediately where they occur, in most cases eliminating the need to seek emergency hospital care. Diastat is administered rectally by the Quick-Dose(TM) delivery system where it is rapidly absorbed, allowing the drug to reach the brain quickly and halting continuous or multiple seizures between five to 15 minutes.
Though most epileptic seizures are brief, isolated, distinct in pattern, and well controlled by existing epilepsy medications, some patients are prone to developing the devastating condition known as ARS. ARS is characterized by the sudden onset of multiple seizures, where patients experience debilitating and repetitive seizures that can occur several times per day or even lead to a condition known as Status Epilepticus (SE) in which seizures can last hours or days. Emergency hospital care has been the required treatment for ARS for decades. Effective treatment of ARS requires fast and powerful medical intervention. Clinical trials involving Diastat, including one recently published in The New England Journal of Medicine,(1) demonstrate the drug safely and effectively aborts episodes of ARS, shortens the duration of seizure clusters and significantly reduces the incidence of seizure A study published in Neurology(2) reported that the ease of administration of Diastat and the convenience for caregivers to carry the treatment with them were definite advantages. The study concluded that Diastat improved the quality of life for caregivers and patients because it provided "a significant reduction in the disruption of everyday life." Improved quality of life encompassed a greater freedom of movement, especially beyond their local communities (able to take vacations) and a feeling of control and empowerment because caregivers could effectively manage severe seizures. The study further noted that the ability to successfully treat ARS in a home environment offered definite economic advantages such as reduced medical costs, fewer emergency room visits, children returning to school more quickly and a reduction in parent/caregiver absence from work. "Diastat represents an enormous step forward in the treatment of this highly troubling form of epilepsy," said Dr. Kevin Farrell, Consulting Neurologist at BC Children's Hospital in Vancouver. "For the first time we now have a treatment that can be safely and easily used by caregivers outside of the hospital setting to manage Acute Repetitive Seizures. Faster treatment means better results for the patient. This treatment can also cut down on the number of emergency room visits, and this helps reduce the cost of healthcare," he added. ARS can lead to life-threatening situations. If left untreated, these seizures may evolve into a much more serious condition known as Status Epilepticus (SE), in which seizures are continuous for more than 30 minutes. SE can cause irreversible brain damage. "The key to blocking the progression of ARS to Status Epilepticus is providing aggressive and immediate treatment during an ARS attack," said Dr. Richard Desbiens, Neurologist and Epileptologist, Neurology Program Director, Université Laval, and Director, Epilepsy Monitoring Unit Director at Centre hospitalier affilié universitaire de Québec, Pavillon Enfant-Jésus. "Delays caused in getting people to the hospital can significantly worsen patient outcomes. A treatment like Diastat will now simplify the way we treat multiple seizures. This is good news indeed for the epilepsy community," he added. "I'm excited about this new option because it will make me feel that I have more control when my son has a seizure," said Doris Burrows, a mother and caregiver whose five-year-old son had his first seizure at 22 months. "Just knowing I can help him immediately, regardless of where we are, is reassuring and gives me greater peace of mind at a very trying time," she added. Epilepsy is the second most common neurological disorder (next to migraines). More than 300,000 Canadians, or one in 100, have active epilepsy. It is defined as a tendency to suffer from seizures, which are temporary alterations in one or more brain functions. During a seizure, an unusual electrical discharge occurs in the brain. Many people with epilepsy lead normal lives and have no symptoms between seizures. Some can tell when an attack is imminent as they experience an aura (a restless, irritable or uncomfortable feeling) shortly before a seizure. "We welcome the news that Diastat is now available for Canadians who suffer from epilepsy and ARS," said Robin Rowe, Education Coordinator, Epilepsy Association. "Epilepsy is a disorder in need of new advances. It is our hope that this new, immediate treatment will help people with epilepsy and their caregivers to better manage their seizures, especially if it means a decrease in emergency or hospital treatment," she added. Diastat is a proprietary gel formulation of diazepam that belongs to the benzodiazepine class of medicines. With instruction from a healthcare professional, Diastat can be administered safely, quickly and discreetly to a patient experiencing a seizure by a caregiver (parents, family members, etc.). Once administered, Diastat starts to work quickly first by reaching desired blood levels and then being simultaneously redistributed into fat and muscle tissue. This unique mode of action prevents dangerous excessive peaks in blood levels and side effects that are associated with intravenous diazepam. Diastat's fast onset of action, combined with the fact that it stays active in the bloodstream at an optimal therapeutic level, provides maximum antiseizure control for up to eight hours and minimizes the risk of side effects. The pre-filled, unit dose delivery system is specially designed for comfort and ease of use. Available in 4.4 cm and 6 cm applicator sizes with soft tips, the system does not leave the patient in additional discomfort following the seizure, and it empowers caregivers to provide immediate help to their loved ones. Most importantly, this accelerated delivery method is an effective alternative to helping a patient who is typically unresponsive and unlikely to be able to swallow oral medication. Diastat does not have special storage requirements and it can be kept at room temperature (no refrigeration required). This allows caregivers and patients to keep Diastat with them at all times, arming them if a seizure occurs. Diastat was shown in clinical trials to be well tolerated. The most common side effect reported was sleepiness which is common to most medicines used to treat epilepsy. The product was approved by the US Food and Drug Administration (FDA) in July, 1997 and by Health Canada's Therapeutic Products Programme in 1998. The product is available only by prescription. Diastat is one of eight neurologic products licensed in Canada in June 1999, exclusively to Draxis by Elan Corporation Plc. Draxis Pharmaceutica is the pharmaceutical division of Canadian healthcare company Draxis Health Inc. Draxis Health Inc. is a diversified specialized pharmaceutical company operating in three niche markets: Companion Animal Health (through its global alliance with Pfizer Inc.), Radiopharmaceuticals (Draximage), and Pharmaceuticals; neurology and dermatology (Draxis Pharmaceutica). Draxis supports its own as well as third party manufacturing requirements through its subsidiary, Draxis Pharma, located in Kirkland, Quebec.
References: (1) Dreifuss FE (deceased), Rosman N, Cloyd JC, Pellock JM, Kuzniecky RI, Lo WD, Matsuo F, Sharp GB, Conry JA, Bergen DC, Bell WE. "A Comparison of Rectal Diazepam Gel and Placebo for Acute Repetitive Seizures." New Engl J Med, 1998; 338; 26: 1869-1875.
Related Links: Draxis Health Inc and Diastat (diazepam rectal gel).
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