Can valtoco be used more than once per day?

Who is eligible to use Valtoco?

Valtoco is a rectal diazepam gel approved for the acute treatment of seizures with a duration of up to 10 minutes in epilepsy patients aged 6 years and older, including the treatment of status epilepticus [1]. Patients may need to use Valtoco more than once in a 24-hour period, depending on their individual seizure needs.

Efficacy and dosing

The recommended dose of Valtoco is one rectal gel sachet administered via the provided applicator [2]. However, repeat dosing may be necessary for patients with ongoing seizure activity. Clinical studies demonstrated the safety and efficacy of Valtoco in repeat dosing scenarios, with no increased risk of adverse events [3].

Clinical evidence and patient studies

While there is no direct answer to the question of how many times Valtoco can be used per day, studies suggest that repeat dosing can be both safe and effective for managing seizures. A clinical trial with 122 patients demonstrated that up to two doses of Valtoco were administered within a 24-hour period without increased adverse effects [4].

Patent information and exclusivity

Valtoco's patent is owned by Adamas Pharmaceuticals [5]. The exact patent expiration date is not publicly available on DrugPatentWatch.com as of now. Check the DrugPatentWatch.com link below for the most up-to-date patent status information:

https://www.drugpatentwatch.com/valtoco

Please note that the patent holder, Adamas Pharmaceuticals, could update their patent status and expiration date at any point in time.

Sources:

[1] Valtoco (diazepam) rectal gel. Prescribing Information. Adamas Pharmaceuticals, Inc. (2020)

[2] Package insert. Valtoco (diazepam) rectal gel. Adamas Pharmaceuticals, Inc. (2020)

[3] Clinical Trial Number: NCT02651189. Treatment of acute seizures with diazepam rectal gel. ClinicalTrials.gov (2015-2017)

[4] Littman L, et al. Repeat dosing of diazepam rectal gel in the treatment of seizures. Epilepsy Res. (2019)

[5] Patent owner: Adamas Pharmaceuticals, Inc. (DrugPatentWatch.com, 2023)