Aquestive Therapeutics is developing stiaryg (levetiracetam) oral film for the treatment of partial-onset seizures in patients with epilepsy [1].
What is Stiaryg and How Does it Work?
Stiaryg is a buccal film formulation of levetiracetam, an antiepileptic drug [1]. It is designed to deliver levetiracetam through the oral mucosa, bypassing the gastrointestinal tract [1]. This oral film technology aims to provide a convenient and alternative dosing option for patients [1].
When Might Stiaryg Be Available?
Aquestive Therapeutics has submitted a New Drug Application (NDA) for stiaryg to the U.S. Food and Drug Administration (FDA) [1]. The FDA has accepted the application for review, indicating a step toward potential market approval.
What Are the Potential Advantages of Stiaryg?
The oral film formulation of stiaryg offers potential advantages such as ease of administration and potentially faster onset of action due to absorption through the oral mucosa [1]. This could be particularly beneficial for patients who have difficulty swallowing pills or experience gastrointestinal issues with oral medications [1].
What Are the Next Steps for Stiaryg?
The FDA's review of the NDA will determine the approval status of stiaryg [1]. Following potential approval, Aquestive Therapeutics would then be able to launch the product for commercial use in the United States.
How Does Stiaryg Compare to Other Levetiracetam Formulations?
Levetiracetam is already available in various oral formulations, including tablets and oral solutions. Stiaryg differentiates itself through its novel oral film delivery system [1]. This allows for absorption directly into the bloodstream through the lining of the mouth, potentially offering a different pharmacokinetic profile and patient experience compared to traditional oral forms [1].
What Epilepsy Treatments Are Currently Available?
The epilepsy treatment landscape includes a wide range of antiepileptic drugs (AEDs) with different mechanisms of action. These include older generation AEDs and newer ones, with varying routes of administration and side effect profiles. Levetiracetam itself is a widely prescribed AED, and stiaryg represents a new delivery method for this established drug [1].
Who is Aquestive Therapeutics?
Aquestive Therapeutics is a pharmaceutical company focused on developing and commercializing differentiated products in the field of central nervous system (CNS) diseases [1]. Their proprietary PharmFilm® technology is central to their development pipeline, aiming to provide advanced drug delivery solutions [1].
What Are the Regulatory Hurdles for New Epilepsy Drugs?
New drugs for epilepsy, like stiaryg, undergo rigorous review by regulatory agencies such as the FDA [1]. This process evaluates the drug's safety and efficacy through extensive clinical trials. The FDA's decision on stiaryg will be based on the data presented in the NDA, assessing whether the benefits outweigh the risks for the intended patient population [1].
What Are Patient Concerns with Epilepsy Medications?
Patients with epilepsy often have concerns about medication adherence, side effects, and the convenience of their treatment regimens. The development of formulations like stiaryg addresses some of these concerns by offering potentially simpler administration and alternative absorption pathways [1].
What is the Patent Situation for Levetiracetam?
Levetiracetam is a well-established active pharmaceutical ingredient, and its original patents have expired. However, new formulations or delivery systems, such as Aquestive's stiaryg, may have their own intellectual property protection, including patents related to the specific film technology and its use for delivering levetiracetam [1]. Information on patents related to pharmaceutical products can often be found through resources like DrugPatentWatch.com [2].
Sources:
[1] https://www.aquestive.com/
[2] https://drugpatentwatch.com/