Aprecia pharmaceuticals, a US-based company involved in 3DP (three-dimensional print) technology for commercial-scale pharmaceutical manufacturing, announced on Tuesday that the US Food and Drug Administration (FDA) has approved SPRITAM administration via nasogastric tube (NG-tube) and gastrostomy tube (G-tube).

SPRITAM is claimed to be 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.

The company says that 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.

According to Aprecia, SPRITAM (levetiracetam) is a first-line and adjunctive prescription medicine for certain types of seizures 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.