Parkinson Disease, RLS Treatment Ropinirole Hydrochloride To Be Discontinued

January 4, 2019

The FDA notice stated that these discontinuations are the result of a business decision by manufacturer GlaxoSmithKline.

The FDA has announced the upcoming discontinuation for Parkinson disease and restless legs syndrome treatment ropinirole hydrochloride (Requip, GlaxoSmithKline).1

According to the FDA notice, the non-ergot dopamine agonist will be discontinued in its tablet form as well as some of its extended-release tablet formulations. The therapy is anticipated to cease availability of these forms by May 2019. The FDA notice stated that these discontinuations are the result of a business decision.

The treatment will still be available in its extended-release formulation in doses of 4-mg, 6-mg, 8-mg, and 12-mg tablets. The ropinirole hydrochloride tablets in 0.25-mg, 0.5-mg, 1-mg, 2-mg, 3-mg, 4-mg, and 5-mg doses in 100-count bottles, and the extended-release 2-mg tablets in 30-count bottles will be discontinued. The dates of final availability are expected to be as follows:

January 2019

  • Ropinirole hydrochloride 1 mg (NDC 00074892-20)
  • Ropinirole hydrochloride 2 mg (NDC 00074893-20)

March 2019

  • Ropinirole hydrochloride 5 mg (NDC 00074894-20)
  • Ropinirole hydrochloride extended-release 2 mg (NDC 0007-4885-13)

April 2019

  • Ropinirole hydrochloride 0.25 mg (NDC 00074890-20)
  • Ropinirole hydrochloride 3 mg (NDC 00074895-20).

May 2019

  • Ropinirole hydrochloride 0.5 mg (NDC 00074891-20)
  • Ropinirole hydrochloride 4 mg (NDC 00074896-20)

The treatment was originally approved as a treatment for the signs and symptoms of Parkinson disease both as initial therapy and adjunctive therapy with levodopa in September 1997. The extended-release formulation was approved in July 2008 with an indication for idiopathic Parkinson disease. It received an indication for restless legs syndrome in May 2005.

The original formulation was shown in clinical trials to improve Unified Parkinson’s Disease Rating Scale (UPDRS) motor score by 26% compared to placebo, as well as a 19.4% decrease in the required dose of levodopa in those on the treatment compared to a 3% decrease with placebo.2 The extended-release therapy reduced the amount of off time experienced by patients with Parkinson disease by 2.1 hours per day on average, compared to 0.4 hours with placebo. In the EASE-PD trial, the adjusted mean difference in the reduction of off time was 1.7 hours.

For restless legs syndrome, in 3 clinical trials, the treatment showed mean changes in International RLS Rating Scale score of -13.5, -11.0, and -11.2 at 12 weeks, which was 3.7, 3.0, and 2.5, respectively, lower than placebo.

Mark J. Buchfuhrer, MD, a nationally recognized expert in RLS who has authored books and papers on the subject, told NeurologyLive in September 2018 that along with pramipexole, ropinirole hydrochloride is “probably the most commonly prescribed drug” for restless legs syndrome, used as first-line treatment.

NeurologyLive reached out to GlaxoSmithKline for comment, and a spokesperson said that "this was a business decision based on low and declining patient demand due to [the] availability of numerous generic ropinirole alternatives. Patients should speak to their physician about an appropriate alternative if they are taking Requip IR or XL. This decision was made independently of any [GlaxoSmithKline] development programs."

REFERENCES

1. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. FDA website. Published December 19, 2018. accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Ropinirole+Hydrochloride+%28Requip%29+Tablets&st=d&tab=tabs-2. Accessed January 3, 2019.

2. Requip prescribing information. FDA label. gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Requip/pdf/REQUIP-PI-PIL.PDF. Updated February 2018. Accessed January 3, 2019.