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Aquestive Therapeutics, a specialist drug developer, recently announced the introduction of Sympazan (clobazam, chlorpyrine) oral membranes in the U.S. market, which can be purchased at retail pharmacies across the U.S. or by mail.
U.S., Sympazan was approved by the U.S. Food and Drug Administration (FDA) in early November to treat Lenox-Gastaut syndrome (LGS)-related seizures in patients 2 years and older. The approval makes Sympazan the first and only oral membrane agent approved by the FDA to treat LGS-related seizures. Previously, chlorpype was listed under the brand name Onfi and is available in two dosage forms, oral tablets and oral suspension.
LGS is a severe and difficult-to-treat type of epilepsy that begins in early childhood and is characterized by multiple types of seizures and intellectual disabilities. Patients with LGS often have difficulty swallowing pills and large volumes of suspension due to physical limitations, behavioral or cognitive effects, which can lead to uncertainty and incognity in the dosage of the drug, increasing the burden of care, especially for patients who may be resistant to treatment.
since it was approved by the FDA in 2011, chlorpyrine tablets and oral suspension (brand name: Onfi) have been trusted complementary therapies for the LGS patient population. In a randomized, double-blind, placebo-controlled Phase III study of 238 LGS patients in the group, chlorpyrides significantly reduced the frequency of seizures (involving falls) by 41% (low dose) to 68% (high dose) and placebo by 12% (all doses vs placebo, p<05).
Sympazan is based on Aquestive's proven PharmaFilm technology development. Several pharmacodynamic studies have been conducted to show that Sympazan oral membranes are biologically equivalent to chlorpyrine tablets and have similar safety characteristics.
Sympazan oral membrane is berry-flavored and has 3 dosage sizes (5mg, 10mg, 20mg) to meet the needs of a wide range of LGS patients and caregivers.
San Inocencio, executive director of the LGSK Foundation, said earlier that many LGS patients have difficulty swallowing pills and suspensions, which makes it difficult for caregivers to take medication. We believe Sympazan oral membranes will be an important treatment that is popular with LGS patient groups and caregivers.
. Kendall, chief executive of Aquestive, said Sympazan's U.S. listing marked an important milestone for the company. The company has established an extensive sales network to ensure that LGS patients have easy access to this important treatment option. (Bio Valley)