Aprecia's SPRITAM® Receives FDA Approval for Tube Administration, Enhancing Patient Access

Aprecia's SPRITAM® Secures FDA Approval for NG and G-tube Administration

Aprecia Pharmaceuticals, a pioneer in the innovative realm of three-dimensional printing (3DP) technology for pharmaceuticals, has made a significant stride in patient care with the recent FDA approval of SPRITAM® (levetiracetam) tablets for administration via nasogastric (NG) and gastrostomy (G) tubes. This marks a crucial development for patients unable to take medications orally, particularly those suffering from seizure disorders.

What is SPRITAM®?

SPRITAM® is renowned as the world's first 3D-printed medication approved for commercial-scale production. Its groundbreaking formulation is designed to disintegrate in mere seconds with a small amount of liquid, making it not only efficient but also highly effective for those in need. This newly approved method of administering the medication expands its accessibility, ensuring it reaches all age groups in need of seizure management.

Addressing Patient Needs

With the unique ability to cater to various administration routes, SPRITAM® allows for flexible dosages suitable for patients with different medical needs. The rapid disintegration capability fosters ease of intake, a vital aspect for individuals who rely on enteral feeding due to challenges in swallowing. Kyle Smith, President and COO of Aprecia, emphasized the importance of this development, stating, "The ability for SPRITAM to disintegrate in minimal fluid volumes supports multiple routes of administration and enhances accessibility for our patients."

Previously, patients who could not ingest medication through traditional means faced a daunting challenge in effectively managing their conditions. The approval for NG and G-tube administration provides a reliable option, ensuring that patients can receive the necessary treatment without compromising on efficacy.

Safety and Efficacy

The efficacy of SPRITAM® when administered through NG and G-tubes has been thoroughly validated by Aprecia's rigorous data analysis, which confirmed that the formulation delivers consistent results across various tube sizes. Kathi Rinesmith, Senior Vice President of Scientific Affairs at Aprecia, explained that the precision of the administration method guarantees that patients relying on enteral feeding have clear guidance on how to utilize SPRITAM® effectively and safely.

The medication acts primarily as a therapy for partial-onset seizures, providing essential relief for those four years and older. Furthermore, it also serves as an adjunctive treatment for specific types of myoclonic and generalized seizures in adolescents and children. This versatility enhances its significance in the therapeutic landscape of epilepsy treatment.

Innovative Manufacturing Technology

Aprecia Pharmaceuticals made waves in the pharmaceutical industry when it introduced its ZipDose® Technology Platform, which underpins the rapid disintegration capabilities of SPRITAM®. This patented technology not only streamlines manufacturing processes but also supports the development of pediatric dosage forms that comply with FDA requirements for clinical studies in younger populations.

Founded in 2003, Aprecia has consistently fostered innovation in pharmaceutical manufacturing. The company's commitment to enhancing the patient experience is evident through its holistic approach to drug development, ensuring safety and efficacy at every level.

Conclusion

With the FDA's approval for NG and G-tube administration of SPRITAM®, Aprecia has made a significant contribution to improving medication accessibility for patients with complex health needs. This pioneering advancement sets a new standard for the administration of anti-seizure medications, ultimately striving to enhance the quality of life for individuals managing epilepsy. Healthcare providers and patients alike can now benefit from more flexible and effective treatment options, tailoring care to individual needs and expanding horizons for seizure management.

To ensure safe use and comprehensive understanding, healthcare providers are encouraged to consult the updated prescribing information detailing preparation and administration protocols.

For more information, visit Aprecia's website.