/PRNewswire/ -- Aprecia, the global leader in 3DP (three-dimensional print) technology for commercial-scale pharmaceutical manufacturing, today announced that the U.S. Food and Drug Administration (FDA) has approved administration via

/PRNewswire/ -- 全球领先的商业规模制药3DP（三维打印）技术公司Aprecia今天宣布，美国食品药品监督管理局（FDA）已批准通过

nasogastric tube (NG-tube)

鼻胃管 (NG-tube)

and

和

gastrostomy tube (G-tube)

胃造口管 (G管)

for SPRITAM.

适用于SPRITAM。

SPRITAM is the world's first, FDA-approved three-dimensionally printed medication manufactured at commercial scale. The approved formulation allows for disintegration in seconds with a small volume of liquid. This approval for administering the drug product via nasogastric tubes (NG-tube) and gastrostomy tubes (G-tube) is based on Aprecia data which confirmed that SPRITAM can be effectively delivered through NG and G-tube sizes appropriate for all indicated age groups..

SPRITAM 是世界上首个获得 FDA 批准的商业规模生产的三维打印药物。该获批配方可在数秒内通过少量液体崩解。基于 Aprecia 数据，确认 SPRITAM 可有效通过适合所有适应症年龄组的鼻胃管（NG 管）和胃造口管（G 管）输送，从而获得了通过这些途径给药的批准。

'Aprecia's advanced manufacturing technology enables disintegration in minimal fluid volumes, supporting multiple oral administration routes and enhancing patient accessibility through a single, adaptable formulation,' said

“Aprecia的先进制造技术使其产品在极少的液体量下即可崩解，支持多种口服给药途径，并通过单一且适应性强的配方提升患者的可及性，”

Kyle Smith

凯尔·史密斯

, President and Chief Operating Officer at Aprecia.

，Aprecia公司的总裁兼首席运营官。

This additional route of administration provides an important option for patients who are unable to take medications by mouth. SPRITAM is the only levetiracetam formulation with FDA approval for NG and G-tube administration.

这种额外的给药途径为无法口服药物的患者提供了一个重要的选择。SPRITAM 是唯一获得 FDA 批准用于鼻胃管和胃管给药的左乙拉西坦制剂。

'

'

Levetiracetam is a first-line therapy for partial onset seizures in patients 4 years and up and its accessibility for patients with swallowing challenges is critical. Aprecia is committed to improving access and flexibility for patients with complex medical needs,' said Smith.

左乙拉西坦是4岁及以上部分性发作癫痫患者的首选疗法，对于有吞咽困难的患者来说，其可及性至关重要。Aprecia公司致力于改善具有复杂医疗需求患者的获取途径和用药灵活性。”史密斯说道。

'Our data demonstrated that, when dispersed in a dosing cup and administered via nasogastric or gastrostomy tube, the formulation maintains consistent delivery characteristics appropriate for enteral administration,' said

“我们的数据显示，当分散在给药杯中并通过鼻胃管或胃造口管给药时，该配方保持了适合肠内给药的一致递送特性，”

Kathi Rinesmith

凯瑟琳·莱因史密斯

, R.Ph, MS, Senior Vice President Scientific Affairs at Aprecia. 'We are pleased that patients and care teams who rely on enteral feeding now have precise instructions to administer SPRITAM without compromising efficacy or safety,' said Rinesmith.

，Aprecia公司的科学事务高级副总裁，R.Ph，MS。里内史密斯表示：“我们很高兴依赖肠内营养的患者和护理团队现在有了精确的指导，可以在不损害疗效或安全性的前提下使用SPRITAM。”

SPRITAM

斯普利塔姆

(levetiracetam) is a first-line and adjunctive prescription medicine for certain types of seizures (see complete indication and important safety information below) that is approved for administration in three ways – dissolving on the tongue with a small sip of liquid, dispersed in a cup with a small volume of liquid and consumed by mouth as a suspension, or dispersed in a cup with water and administered via a nasogastric or gastrostomy tube..

(左乙拉西坦) 是某些类型癫痫发作的一线和辅助处方药（见下文的完整适应症和重要安全信息），被批准以三种方式给药——用少量液体溶解在舌头上，分散在杯中用少量液体作为混悬液口服，或分散在杯中用水稀释后通过鼻胃管或胃造口管给药。

Healthcare providers can refer to the updated prescribing information for detailed instructions on preparation and administration.

医疗保健提供者可以查阅更新的处方信息，了解有关准备和管理的详细说明。

About Aprecia

关于Aprecia

Founded in 2003, Aprecia received the first and only FDA approved three-dimensionally-printed (3DP) pharmaceutical product approval in 2015 and is the global leader in utilizing 3DP technology for commercial-scale, pharmaceutical manufacturing. Aprecia's proprietary 3DP technology includes a multi-patented, binder-jetting manufacturing system.

成立于2003年的Aprecia公司在2015年获得了首个且唯一的FDA批准的三维打印（3DP）药物产品，并且是利用3DP技术进行商业化规模制药的全球领导者。Aprecia的专有3DP技术包括一个多专利的粘合剂喷射制造系统。

Aprecia uses its ZipDose.

Aprecia使用其ZipDose技术。

Technology Platform to create rapidly disintegrating oral dosage forms that are easy to take and easy to administer. Aprecia licenses its exclusive technology platform to pharmaceutical partners to extend product lines and improve patient reach and experience. The platform also provides pediatric dosage form options to address FDA pediatric study requirements.

用于创建易于服用和管理的快速崩解口服剂型的技术平台。Aprecia 将其独家技术平台授权给制药合作伙伴，以扩展产品线并提升患者覆盖范围和体验。该平台还提供儿科剂型选项，以满足 FDA 的儿科研究要求。