Sedor Pharmaceuticals, a partner of Ligand Pharmaceuticals, has recently received FDA approval for SESQUIENT, its status epilepticus treatment. It has been cleared for the treatment of both adult and pediatric patients, and it will hopefully lead to faster and more efficient care.
About Status Epilepticus
Status epilepticus is a rare and possibly fatal condition characterized by seizures that are nonstop and last for five minutes or longer or more than one seizure in this time period without regaining consciousness. It does not affect the majority of people with epilepsy, but this medical emergency does tend to affect young children or the elderly. It is estimated that there are about 150,000 cases every year in the U.S., which translates to about 55,000 fatalities. Without medical intervention, SE can result in permanent damage to the body and brain or even death.
Symptoms of SE include recurring seizures without regaining consciousness, seizures lasting five minutes or longer, loss of consciousness, falling, clenched jaw, jerking and clinching muscle spasms, unusual breathing, inability to speak, “far-off” look or staring, and a lack of control of the bladder and bowels. After these symptoms are noticed, doctors will conduct a full examination. In terms of treatment, it is very important that swift medical intervention occurs. Doctors will immediately treat the seizure itself while also trying to find out the underlying cause. Treatments include glucose for low blood pressure, oxygen, lorazepam, diazepam, phenobarbital, valproate, and fosphenytoin.
SESQUIENT is the only room-temperature stable form of fosphenytoin sodium that has been approved by the FDA. Its approval applies to both adult and pediatric patients with generalized tonic-clonic status epilepticus. It is intended for the treatment and prevention of seizures that occur during neurosurgery, and it can also be used in place of oral phenytoin when it is not available.
It allows point-of-care storage, along with efficient and fast use in emergency rooms, long-term care facilities, intensive care units, and first responder vehicles. Sedor is working to license the commercial rights to SESQUIENT in Europe, North America, and a number of other places, excluding China, where it has already been licensed.
Researchers are very excited and proud of their work on this treatment, as they know that it will be able to help patients. They are thankful to the FDA and proud of the work they have done throughout the regulatory process.
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