Pyros Pharmaceuticals Announces VIGPODER™ (vigabatrin) is Now Available

PARSIPPANY, N.J.--(BUSINESS WIRE)--Pyros Pharmaceuticals, Inc. (Pyros or the Company), 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.”

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.¹ 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.² 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.³

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.^4,5 This release is thought to enhance seizure control for patients by modulating neuronal excitability.⁶ Vigabatrin's mechanism of action underscores its importance in treating seizure disorders.⁷ Its impact may extend beyond seizure management, with emerging research indicating potential benefits in mitigating neurodevelopmental complications associated with certain epilepsy syndromes.⁸

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.*

INDICATION

VIGPODER™ (vigabatrin) is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

Please refer to the full Prescribing Information to view other approved indications.

IMPORTANT SAFETY INFORMATION FOR VIGPODER™ (vigabatrin)

WARNING: PERMANENT VISION LOSS See full Prescribing Information for complete BOXED WARNING.   VIGPODER™ can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGPODER™ may also decrease visual acuity. Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to VIGPODER™ known to be free of risk of vision loss. Risk of new and worsening vision loss continues as long as VIGPODER™ is used, and possibly after discontinuing VIGPODER™. Baseline and periodic vision assessment is recommended for patients on VIGPODER™. However, this assessment cannot always prevent vision damage. VIGPODER™ is available only through a restricted program called the Vigabatrin REMS Program.

WARNINGS AND PRECAUTIONS

• Because of this risk and because VIGPODER™, 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 is difficult, vision loss may not be detected until it is severe.
• Due to the risk of permanent vision loss, VIGPODER™ is only available through the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. 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.
• VIGPODER™ should be withdrawn gradually to avoid withdrawal seizures.
• Patients and caregivers should be told not to suddenly discontinue VIGPODER™ therapy.
• Monitor for symptoms of anemia.
• VIGPODER™ 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.

ADVERSE REACTIONS

The most common (>5%) adverse reactions that occurred more frequently than placebo patients were somnolence, bronchitis, ear infection, and acute otitis media.

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.

References

1. Mackay, M. T., Weiss, S. K., Adams-Webber, T., et al. (2004). Practice parameter: medical treatment of infantile spasms. Report of the American Academy of Neurology and the Child Neurology Society. Neurology, 62(10), 1668-1681.
2. Lux, A. L., & Osborne, J. P. (2004). A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group. Epilepsia, 45(11), 1416-1428.
3. Pellock, J. M., Hrachovy, R., Shinnar, S., et al. (2010). Infantile spasms: a U.S. consensus report. Epilepsia, 51(10), 2175-2189.
4. Cilio, M. R., & Cross, H. J. (2011). Vigabatrin. Neurotherapeutics, 8(2), 330–337.
5. Löscher, W., & Schmidt, D. (2004). New horizons in the development of antiepileptic drugs: innovative strategies. Epilepsy Research, 60(2–3), 77–159.
6. Houston, S. M., & Smart, T. G. (2006). GABA pharmacology: the search for analgesics. Current Opinion in Investigational Drugs, 7(1), 48–55.
7. Wheless, J. W. (2004). Vigabatrin: efficacy and safety in pediatric epilepsy. Journal of Child Neurology, 19(Suppl 1), S21–S29.
8. Chiron, C. (2006). Vigabatrin in the treatment of epilepsy: literature review. Epileptic Disorders, 8(S1), S33–S38.

*SABRIL^® is a registered trademark of Lundbeck.