SPRITAM® (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube Administration

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Jul 22, 2025, 09:00 ET

SPRITAM is the only levetiracetam formulation with FDA-approved labeling for NG-tube and G-tube administration

MASON, Ohio, July 22, 2025 /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 nasogastric tube (NG-tube) and gastrostomy tube (G-tube) for 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.

"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 Kyle Smith, President and Chief Operating Officer at Aprecia.

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.

"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.

"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 Kathi Rinesmith, 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.

SPRITAM (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.

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

About 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. Aprecia uses its ZipDose^® 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. For more information, visit www.aprecia.com.

Important Safety Information for SPRITAM^® (levetiracetam) tablets, for oral suspension

INDICATIONS AND USAGE

SPRITAM (levetiracetam) is a prescription medicine used to treat partial-onset seizures in people 4 years of age and older. SPRITAM is also used with other medicines to treat myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy. SPRITAM is recommended for use in people weighing more than 44 pounds (20 kilograms).

IMPORTANT SAFETY INFORMATION

SPRITAM may not be for everyone. Ask your healthcare provider if SPRITAM is right for you. Do not take SPRITAM if you are allergic to levetiracetam.

WARNINGS AND PRECAUTIONS

Antiepileptic drugs, including SPRITAM, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self-harm that you have never had before or may be worse than before.

SPRITAM may cause extreme sleepiness, tiredness, and weakness, and problems with muscle coordination. You should not drive, operate machinery or do other dangerous activities until you know how SPRITAM affects you.

SPRITAM can cause serious allergic reactions after the first dose or at any time during treatment. Discontinue SPRITAM and seek immediate medical attention if you have allergic reactions such as swelling of the face, lips, eyes, tongue and throat, trouble swallowing or breathing, and hives.

Serious skin rashes can happen after you start taking SPRITAM. There is no way to tell if a mild rash will become a serious reaction. Call your healthcare provider right away at the first sign of rash.

Serious allergic reactions can happen after you start taking SPRITAM and may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This can be life-threatening and can cause death if it is not treated as early as possible. Call your healthcare provider right away if you have a skin rash, fever, swollen glands that do not go away, swelling of your face, shortness of breath, dark urine, or yellowing of the skin or whites of the eyes.

Do not stop taking SPRITAM unless instructed by your healthcare provider. Stopping a seizure medication suddenly can cause you to have seizures more often or seizures that will not stop, which is a very serious problem.

If you become pregnant or intend to become pregnant, contact your healthcare provider right away.

COMMON ADVERSE REACTIONS

In clinical trials, the most common side effects seen in adults who take SPRITAM include sleepiness, weakness, dizziness, and infection. In addition to those previously listed, the most common side effects seen in children who take SPRITAM include tiredness, acting aggressive, nasal congestion, decreased appetite, and irritability.

Talk to your healthcare provider about other possible side effects with SPRITAM. You are encouraged to report side effects of prescription drugs to the FDA at 1-800-FDA-1088 or visiting www.fda.gov/medwatch. You may also report side effects to Aprecia Pharmaceuticals, LLC at 1-844-882-7732.

ADMINISTRATION

SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid, one tablet at a time. As a main way to take SPRITAM, place a tablet on the tongue with a dry hand, and then take a sip of liquid. SPRITAM should be swallowed only after the tablet disintegrates in the mouth. SPRITAM should not be swallowed intact. Partial tablet(s) should not be administered.

Alternately, add whole SPRITAM tablet(s) to a small amount of liquid in a cup and swirl gently. Swallow right after the tablet(s) fully breaks apart (disperses) in the liquid. If there is any mixture left in the cup, rinse with a small amount of liquid, swirl and swallow the remaining contents.

SPRITAM may also be given using a nasogastric or gastrostomy feeding tube. Place the prescribed number of whole tablets in a dosing cup with approximately 10 mL of room temperature water and gently swirl until the tablets break apart in the liquid. Draw up the mixture into a 10 mL oral catheter-tip syringe, hold the syringe vertically, and right away push the mixture into the feeding tube. After giving SPRITAM through the feeding tube, flush the feeding tube two times by repeating this method with an additional 10 mL of room temperature water in the same cup to make sure the full dose is given.

For additional safety information, please see U.S. Full Prescribing Information and Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

Manufactured by Aprecia Pharmaceuticals, LLC, Mason, OH 45040 USA
Distributed by Prasco, LLC, Mason, OH 45040 USA

SOURCE Aprecia Pharmaceuticals