Vitruvias Therapeutics, a US-based finished-dose generic drug manufacturer, has announced the US launch of a bioequivalent, FDA-approved version of the antiarrhythmic drug Rythmol SR, in collaboration with the Chinese pharmaceutical company Sinotherapeutics. The product, known generically as propafenone hydrochloride, is being introduced as an extended-release version of the original Rythmol SR.

Rythmol SR is an oral medication commonly used for treating sustained ventricular tachycardia, a potentially life-threatening heart condition. The FDA-approved formulation is available in extended-release capsules with dosages of 225 mg, 325 mg, and 425 mg, providing a critical option for patients with certain arrhythmias.

Key Benefits and Approvals

Rythmol SR serves multiple purposes, including the conversion and maintenance of sinus rhythm in patients suffering from supraventricular arrhythmias, especially those without structural heart disease. It is also indicated for maintaining sinus rhythm in patients with paroxysmal atrial fibrillation or atrial flutter, which causes disabling symptoms.

According to Vitruvias Therapeutics, the initial dosage of Rythmol SR should be carefully initiated in a hospital setting to monitor its effectiveness and adjust dosages as necessary.

Strong Partnership for Market Penetration

The partnership between Vitruvias and Sinotherapeutics marks a significant step in bringing this life-saving drug to the US market. Dr. Jason Wan, Founder and CEO of Sinotherapeutics, expressed satisfaction with the collaboration, noting that while both companies are relatively young, they have rapidly grown through hard work and persistence in the challenging US market. He stated, “We are confident they will maximize the value of our asset and we look forward to their future participation with other products in our very robust pipeline.”

On the other hand, Carl Whatley, Chairman and CEO of Vitruvias, highlighted the value of Sinotherapeutics’ expertise and resources, emphasizing that the partnership has allowed them to formulate high-barrier generics. Whatley commended Dr. Wan and his team for their efforts in Shanghai, as they continue to file additional abbreviated new drug applications (ANDAs) for other products in the pipeline.

Expert Opinion on Market Outlook

The market for antiarrhythmic drugs, particularly generics, continues to grow as healthcare systems look for cost-effective solutions for managing arrhythmias. The entry of Vitruvias and Sinotherapeutics into this segment could not come at a more crucial time. With ongoing concerns about affordability and access to medications, the bioequivalent version of Rythmol SR is likely to capture market share from its brand-name counterpart, offering an important treatment option to patients.

  Carl Whatley, FDA, Jason Wan, propafenone hydrochloride, Rythmol SR, Sinotherapeutics, Vitruvias Therapeutics