Somerset, N.J. – September 4, 2018 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced a commercial supply agreement with 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 FlexDoseSM 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.
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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 $2.5 billion 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:
- Infantile Spasms (IS) in babies 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking vigabatrin are more important than the possible risk of vision loss.
- Refractory Complex Partial Seizures (CPS) used along with other treatments to treat adults and children 10 years and older if:
- The CPS does not respond well enough to several other treatments, and
- You and your healthcare provider decide the possible benefit of taking vigabatrin is more important than the risk of vision loss.
Vigabatrin should not be the first medicine used to treat CPS.
WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGABATRIN?
- Because vigabatrin might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you.
- Vigabatrin can damage the vision of anyone who takes it. People who take vigabatrin do not lose all of their vision, but some people can have severe loss, particularly their peripheral vision. With severe vision loss, you may have "tunnel vision". You may also have blurry vision. If this happens, it will not get better.
- Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting vigabatrin; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
- Regular vision testing is recommended. It is recommended that your healthcare provider test your (or your child’s) vision before, during, and after treatment with vigabatrin. Regular vision testing is important because damage can happen before any changes are noticed.
- Vision tests cannot prevent the vision damage that can happen with vigabatrin, but they do allow vigabatrin to be stopped if vision has gotten worse. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
- If you do not have these vision tests, your healthcare provider may stop prescribing vigabatrin for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing vigabatrin, but will not be able to watch for any vision loss.
- Magnetic resonance imaging (MRI) changes in babies with IS. Brain pictures taken by MRI show changes in some babies after they are given vigabatrin. It is not known if these changes are harmful.
- Risk of suicidal thoughts or actions. Like other antiepileptic drugs, vigabatrin may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you experience these effects, or any symptoms of depression or mood changes.
- Do not stop vigabatrin without first talking to a healthcare provider. Stopping vigabatrin suddenly can cause seizures that will not stop.
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.
Visit www.fda.gov/medwatch, or call 1-800-332-1088.