Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, recently announced a commercial supply agreement for Aucta Pharmaceuticals, Inc.’s (Aucta) vigabatrin. The agreement follows a successful development program to formulate vigabatrin into a novel dosage form that employs Catalent’s proprietary FlexDose services.
Aucta's commercial partner, Upsher-Smith Laboratories, LLC (Upsher-Smith), will launch vigabatrin for oral solution under the brand name Vigadrone, which offers patients and physicians a fully substitutable generic alternative to Sabril (vigabatrin) powder for oral solution.*
Under the terms of the manufacturing agreement, Catalent undertook the FlexDose development program, integrating the development of granulated drug product with stick-pack dose design, packaging and commercial manufacture of vigabatrin at its 166,000-square foot flagship European manufacturing facility in Schorndorf, Germany. This will be the first U.S. FDA Abbreviated New Drug Application (ANDA) to employ Catalent’s proprietary FlexDose services, and the first to be commercialized in Schorndorf.
“Catalent has over a decade of experience in developing, manufacturing and packaging stick pack products, which offer a number of advantages to improve the convenience of dosing and patient adherence of drug products,” commented Jonathan Arnold, Catalent’s President, Oral Drug Delivery.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5B in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.
About Aucta Pharmaceuticals, Inc.
Aucta Pharmaceuticals, Inc. (AUCTA, Latin-improved, enhanced) is a technology based product company focusing on development and commercialization of niche generic and branded specialty products. The company’s corporate strategy is to focus on proven molecules, use 505(b)(2) regulatory pathway and through innovation, creating new therapeutics with lower scientific risk and meet unmet medical needs in attractive market. Its specialty division has a therapeutic focus in CNS, Dermatology and Pediatrics. For more information, visit www.auctapharma.com.
*Sabril is a registered trademark of Lundbeck.
What Is Vigabatrin?
Vigabatrin for Oral Solution is a prescription medicine used for the treatment of:
Vigabatrin should not be the first medicine used to treat CPS.
What Important Safety Information Should I Know About Vigabatrin?
Vigabatrin can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because vigabatrin causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. Vigabatrin may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
Before starting vigabatrin, tell your doctor about all of your (or your child’s) medical conditions, including mental illnesses, and all the medicines you (or your child) take.
If you are breastfeeding or plan to breastfeed, vigabatrin can pass into breast milk and may harm your baby.
If you are pregnant or plan to become pregnant, it is not known if vigabatrin will harm your unborn baby. You and your healthcare provider will have to decide if you should take vigabatrin while you are pregnant.
The most common side effects of vigabatrin in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, and eye problems like blurry vision, double vision, and eye movements that cannot be controlled.
The most common side effects of vigabatrin in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredness, and aggression. Also expect side effects like those seen in adults.
The most common side effects of vigabatrin in babies include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, swelling in the bronchial tubes (bronchitis), ear infection, and irritability.
Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away.
This is the most important information to know about vigabatrin, but not all of the possible side effects of vigabatrin. For more information, ask your healthcare provider or pharmacist, or please visit vigadrone.com/PI for vigabatrin Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use.
You are encouraged to report negative side effects of prescription drugs to the FDA.
For more information, visit www.fda.gov/medwatch.
SOURCE: Catalent, Inc.