The first ever drug manufactured using 3D printing technology is now available to US patients with epilepsy.
Aprecia Pharmaceutical’s Spritam was approved by the FDA in August last year, with industry experts hailing it as the catalyst for a new era in drug development.
Spritam (levetiracetam) is an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in both adults and children aged four years and older with epilepsy.
The drug is created using a combination of 3D printing technology and formulation science – Aprecia’s patented ZipDose technology – allowing the dosage to be easily tailored to each individual patient’s requirements.
The treatment is designed to provide a new, “patient-friendly” option for those who find taking medication difficult.
A survey undertaken by Hermes Pharma in 2014 found that 40-50% of participants have experienced difficulty swallowing tablets and capsules, with 8% admitting to skipping doses as a result.
The 3D printing of Spritam enables it to be produced as a porous formulation that rapidly disintegrates with a sip of liquid – even at high doses.
Don Wetherhold, chief executive of Aprecia, said: “Spritam is designed to transform what it is like to take epilepsy medication, and is the first in a line of products we are developing to provide patients and their caregivers with additional treatment options.”
Aprecia will primarily focus its ZipDose technology on the central nervous system therapeutic area where there is a real need for medicines that are easy to take, it said in a statement.
Nearly three million people live with epilepsy in the US, with approximately 150,000 new cases being diagnosed every year.