PARSIPPANY, N.J. – Pyros Pharmaceuticals, Inc., a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today that VIGPODER™ (vigabatrin) for oral solution, USP, a treatment for appropriate patients with infantile spasms (IS), is now available. As a therapeutically equivalent product, VIGPODER™ is anticipated to offer the same safety and efficacy profile as SABRIL® (vigabatrin) for oral solution. Please see full Prescribing Information to view other approved indications, BOXED WARNINGS, and Important Safety Information.
Infantile spasms, a rare but serious form of epilepsy, poses significant challenges for patients and their families. With VIGPODER™, Pyros aims to provide reliable services and an affordable treatment option, ensuring that families faced with an IS diagnosis, and whose children are prescribed vigabatrin, can rapidly obtain this essential therapy. Additionally, Pyros Total Care™, the Company’s personalized comprehensive support program, is available to assist families throughout the treatment journey.
“The launch of VIGPODER™ and the Pyros Total Care™ program underscores our dedication to supporting families facing the challenges of infantile spasms,” stated Michael Smith, Chief Executive Officer at Pyros. “We strive to elevate the overall treatment experience and offer comprehensive support to families navigating this challenging journey. Moreover, we are committed to initiatives aimed at accelerating symptom recognition and referrals to neurologists.”
About Pyros Total Care™
As part of the Company’s commitment to prioritizing patient access to treatments for those who need them most, Pyros is providing ongoing personalized support service to caregivers through Pyros Total Care™ for those prescribed VIGPODER™. The support program offers personal assistance and financial resources to caregivers whose child is starting or continuing therapy.
Our dedicated support team includes a nurse educator, reimbursement support, and a clinical pharmacist. For more information, visit PyrosTotalCare.com or call 1-888-760-8330, Monday to Friday, 8 a.m. to 5 p.m. Central Time.
About Infantile Spasms
Infantile spasms (IS) is a rare, severe form of epilepsy that typically begins in children less than one year old. Infantile spasms can appear as subtle but repetitive movements that can often be overlooked or misdiagnosed. IS can lead to long-term permanent issues such as continued seizures, other forms of epilepsy, autism spectrum disorder, and developmental issues. The American Academy of Neurology conducted a systematic review of treatment for IS and concluded that successful treatment of IS can improve the long-term prognosis.
About Vigabatrin
Vigabatrin is a medication used in the treatment of infantile spasms and is designed to inhibit the enzyme GABA transaminase, consequently increasing gamma-aminobutyric acid (GABA) levels in the brain. This release is thought to enhance seizure control for patients by modulating neuronal excitability. Vigabatrin’s mechanism of action underscores its importance in treating seizure disorders. Its impact may extend beyond seizure management, with emerging research indicating potential benefits in mitigating neurodevelopmental complications associated with certain epilepsy syndromes.
Vigabatrin REMS Program
The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.
Healthcare providers must be certified in the Vigabatrin REMS Program to prescribe VIGPODER™ and patients must be enrolled in the Vigabatrin REMS Program to receive VIGPODER™. Certified prescribers and patients enrolled in the Vigabatrin REMS Program remain in the Vigabatrin REMS Program and do not need to recertify or re-enroll.
About Pyros
Pyros Pharmaceuticals is developing enhanced specialty pharmaceuticals for rare diseases. Our mission is to elevate the standard of care for infantile spasms, providing treatment options that significantly improve the lives of affected children. Through our enhanced therapies and comprehensive support services, we aim to assist providers and caregivers in navigating the complexities of the patient journey.
Contact
Edwin Urrutia
Chief Operating Officer
[email protected]
201-743-9468