PARSIPPANY, N.J.--(BUSINESS WIRE)--Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, is pleased to announce that VIGAFYDE™ (vigabatrin) oral solution is now available. VIGAFYDE™ is the first and only ready-to-use vigabatrin oral solution, indicated as a monotherapy for the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss. Please see full Prescribing Information below to view Important Safety Information, including BOXED WARNINGS.
AnovoRx has been designated as the exclusive specialty pharmacy for VIGAFYDE™, ensuring a streamlined process for patients and caregivers to access this critical treatment. Additionally, comprehensive support for families is provided through Pyros Total Care™, accessible via PyrosTotalCare.com.
“The availability of VIGAFYDE™ represents a significant advancement in the treatment landscape for infantile spasms. This ready-to-use formulation offers patients and caregivers a simpler dosing process and enhances the likelihood of accurate dosing of infants facing this very serious seizure disorder,” said Michael Smith, co-founder and Chief Executive Officer of Pyros.
“VIGAFYDE™ is more than just a new formulation; it’s a critical advancement in the treatment of infantile spasms that directly addresses the needs of both patients and caregivers. This launch reinforces Pyros' commitment to delivering innovative therapies that have a profound and lasting impact on the lives of those affected by rare pediatric epilepsies,” stated Edwin Urrutia, co-founder and Chief Operating Officer of Pyros.
About VIGAFYDE™ and Infantile Spasms
VIGAFYDE™ is a ready-to-use vigabatrin oral solution indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
Infantile spasms (IS) is a rare, severe form of epilepsy that typically begins in children less than one year old. Early and accurate diagnosis, followed by timely treatment, is critical for improving long-term outcomes.
About Pyros Total Care™
Pyros Total Care™ provides personalized support to families throughout their treatment journey, including assistance from nurse educators, reimbursement support, and clinical pharmacists. For more information, visit PyrosTotalCare.com or call 1-888-760-8330.
For more information on VIGAFYDE™, please visit pyrospharma.com.
Vigabatrin REMS
The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS. This strategy is mandated by the FDA to ensure that patients and healthcare providers make informed risk-benefit decisions before starting treatment, and to ensure the proper use of vigabatrin throughout the treatment process.
Healthcare providers must be certified in the Vigabatrin REMS to prescribe VIGAFYDE™, and patients must be enrolled in the Vigabatrin REMS to receive VIGAFYDE™. Once certified and enrolled, prescribers and patients remain in the Vigabatrin REMS and do not need to undergo recertification or re-enrollment.
INDICATION
VIGAFYDE™ (vigabatrin) is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin)
WARNING: PERMANENT VISION LOSS |
See full Prescribing Information for complete BOXED WARNING. |
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WARNINGS AND PRECAUTIONS
- VIGAFYDE can cause permanent vision loss. Because of this risk and because VIGAFYDE, when it is effective, provides an observable symptomatic benefit; patient response and continued need for treatment should be periodically assessed.
- Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is recommended. Because vision testing in infants and children is difficult, vision loss may not be detected until it is severe. VIGAFYDE is not approved for use in pediatric patients older than 2 years of age or in adults.
- Due to the risk of permanent vision loss, VIGAFYDE is only available through the Vigabatrin REMS. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.
- Abnormal Magnetic Resonance Imaging (MRI) signal changes and Intramyelinic Edema (IME) in some infants and young children treated with vigabatrin have been observed. These changes generally resolved with discontinuation of treatment and resolved in a few patients despite continued use.
- VIGAFYDE should be withdrawn gradually to avoid withdrawal seizures. Patients and caregivers should be told not to suddenly discontinue VIGAFYDE therapy.
- Monitor for symptoms of anemia.
- VIGAFYDE causes somnolence and fatigue.
- In pediatric clinical trials (pooled data), the incidence of peripheral neuropathy and edema observed in pediatric patients was similar on vigabatrin and placebo.
- VIGAFYDE causes weight gain in pediatric patients.
ADVERSE REACTIONS
Most common (≥10%) adverse reactions in patient receiving low-dose (18-36 mg/kg/day) vs high-dose (100-148 mg/kg/day) vigabatrin, respectively, were upper respiratory tract infection (51%, 46%), otitis media (44%, 30%), fever (29%, 19%), viral infection (20%, 19%), sedation (19%, 17%), somnolence (17%, 19%), irritability (16%, 23%), constipation (14%, 12%), vomiting (14%, 20%), diarrhea (13%, 12%), nasal congestion (13%, 4%), pneumonia (13%, 11%), insomnia (10%, 12%), ear infection (7%, 14%), and rash (8%, 11%).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or Pyros at 1-855-406-1010.
Please see full Prescribing Information, including BOXED WARNING, for additional Important Safety Information.
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.
For more information, please visit: www.pyrospharma.com
Forward-Looking Statements
The Company has made statements throughout this press release which constitute forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any results, levels of activity, performance or achievements expressed or implied by any such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “hopes,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “likely,” “potential,” or “continue” or the negative of these terms and similar words. Although management believe that the expectations reflected in these forward-looking statements are reasonable, management cannot guarantee future results, levels of activity, performance or achievements. Furthermore, management undertakes no obligation to update any forward-looking statements for any reason unless required to do so by law.
SOURCE Pyros Pharmaceuticals, Inc.
