CINCINNATI, Sept. 30, 2019 /PRNewswire/ --Aprecia, the 3DP PharmaceuticalCompany, today announced that Lynda Harker, RPh, will lead the company's national sales team to accelerate the promotion of SPRITAM® (levetiracetam)Tablets for Oral Suspension, an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures for patients with certain types of epilepsy. Harker and Aprecia's national sales team will be poised to launch renewed promotional efforts of SPRITAM in October 2019.
"Lynda is a top performer with both clinical and commercial pharmaceutical expertise," said Chris Gilmore, Aprecia's Chief Executive Officer. "Her sales leadership roles in specialty and primary care at both Eli Lilly and VMS Biomarketing will prove valuable for establishing Aprecia's national sales organization."
"My enthusiasm and passion for better patient experience are a perfect match with Aprecia's mission to address unmet healthcare needs. I believe the unique dosage forms that can be created with 3DP technology will be a breakthrough for patients who otherwise struggle to take their medicine," said Harker.
Harker brings extensive sales and sales management experience across multiple therapeutic categories, most recently as Oncology National Business Manager for VMS Biomarketing. Prior to that role, Harker achieved multiple awards and served in various roles of sales leadership in 17 years at Eli Lilly.
About SPRITAM (SPREE-tam) Tablets, for Oral Suspension SPRITAM is formulated with Aprecia's proprietary ZipDose® Technology, which combines the precision of 3D printing and formulation science to produce rapidly disintegrating formulations of medications. This innovative product disintegrates in the mouth with a sip of liquid and offers an option which may improve compliance for patients who may struggle to take their medicine. Manufactured in a regulated commercial-scale facility, SPRITAM is available in four unit-dose strengths, including 250 mg, 500 mg, 750 mg and 1,000 mg.
INDICATIONS AND USAGE SPRITAM (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 4 years of age and older with epilepsy, 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 20 kg (44 lbs) or more.
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 severe 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 if you get a rash while taking SPRITAM.
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 people 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 negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatchor call 1-800-FDA-1088.
ADMINISTRATION SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. As a primary method of administration, 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 volume of liquid in a cup and swirl gently. Swallow right after the tablet(s) disintegrate. If there is any medicine left in the cup, rinse with a small volume of liquid, swirl and swallow the remaining contents.
About Aprecia Founded in 2003, Aprecia Pharmaceuticalsreceived the first and only FDA approved three-dimensionally-printed (3DP) pharmaceutical product approval in 2015. Aprecia uses its ZipDose® Technology to create rapidly disintegrating oral dosage forms that are easy to take and easy to administer. Without compression during the 3DP manufacturing process, engineered and coated particles such as taste masking and modified release are possible on large dose products (over 1000 mg). Additionally, with the ease of swallowing 3D-printed tablets even at large doses, some patients may experience a reduction in pill burden by achieving their prescribed dose with fewer tablets. Aprecia directly owns a patent estate for novel 3DP machines and pharmaceutical 3DP applications and licenses its exclusive technology platform to pharmaceutical partners as a means to extend product lines, improve patient reach and experience, and address FDA requirements as a pediatric delivery form. For more information, visit www.aprecia.com.
SPRITAM® is manufactured by Aprecia Pharmaceuticals, LLC, Blue Ash, OH 45242 USA, and is distributed by Prasco, LLC, Mason, OH 45040 USA.