Trial Profile
An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 10 Aug 2022
Price :
$35
*
At a glance
- Drugs Arbaclofen (Primary)
- Indications Multiple sclerosis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms OS440-3005
- Sponsors RVL Pharmaceuticals
- 21 Apr 2022 Status changed from active, no longer recruiting to completed.
- 30 Mar 2021 According to an Osmotica Pharmaceutical media release, the company had constructive Type A meeting with the FDA and the company is exploring a number of options define a path forward, which will most likely include another clinical trial.
- 29 Dec 2020 According to an Osmotica Pharmaceutical media release, the company intends to review the CRL with its advisors and to request a meeting with the FDA to discuss their recommendations.