Solriamfetol soon available for narcolepsy?

News Patient news

Written by Estelle B. and published on 06/01/2020

It is difficult to obtain accurate statistics on the prevalence of narcolepsya in France, as the disease is widely under-diagnosed. For patients, a new hope is emerging with the upcoming arrival of a new drug, the solriamfetol. Explanations.


Narcolepsy and solriamfetol

The narcolepsya is the most common clinical form ofhypersomnia. Few drug treatments are currently available for this severe form of sleepiness, which has a profound impact on the quality of life of patients and their families.

In this context, the development of each new drug is carefully monitored by patients, patient organisations and medical teams. This is the case for solriamfetolwhich could soon become a new drug for narcolepsy.

A new weapon against excessive daytime sleepiness

One of the most troublesome symptoms of narcolepsya is excessive daytime sleepiness, which is also found inobstructive sleep apnea. The first-line treatment for these disorders is currently continuous positive airway pressure. But this therapeutic approach is not effective in all narcoleptic patients.

Good to know! Continuous Positive Airway Pressure (CPAP) is an assisted breathing technique used in the treatment of certain breathing disorders, such as sleep apnoea.

The solriamfetol is a new drug, which has already been tested in 4 randomised placebo-controlled clinical trials. In each case, the solriamfetol has been shown to be more effective than placebo. This drug has several beneficial effects in patients with narcolepsy:

  • It improves the level of alertness;
  • It reduces excessive daytime sleepiness.

It has been successfully tested in patients with narcolepsy, with or without cataplexy, and in patients with obstructive sleep apnoea syndrome, whose excessive daytime sleepiness was not significantly reduced by CPAP.

Possible marketing in the next few months?

Following the results of the clinical trials, the pharmaceutical company that developed the solriamfetol submitted a marketing authorisation application to the European Medicines Agency (EMA) in November 2018. In November 2019, the European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive opinion recommending a marketing authorisation for solriamfetol.

This opinion is a key step in making available a new treatment for narcolepsya. The solriamfetol could soon be authorised on the European market with two different dosages:

  • In doses of 75 mg or 150 mg once daily for patients with narcolepsy;
  • In doses of 37.5 mg, 75 mg or 150 mg once daily for patients with obstructive sleep apnoea.

The decision of the European Community is expected within two months of the positive opinion of the European Medicines Agency. This decision is eagerly awaited by patients and could greatly improve their daily lives.

Estelle B., Doctor of Pharmacy

- Jazz Pharmaceuticals receives a positive CHMP opinion for Sunosi®. MYPHARMA. Accessed 30 December 2019.
- Sunosi. Solriamfetol. Opinion. EMA. Accessed 30 December 2019.

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