Jazz Pharmaceuticals announced that the FDA approved Sunosi (solriamfetol) to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnoea. The company noted that the once-daily drug is the first dual-acting dopamine and norepinephrine reuptake inhibitor authorised in this indication.

According to Jazz, Sunosi will be commercially available following a final scheduling decision by the US Drug Enforcement Administration, which typically comes within 90 days of FDA approval. The company said that Sunosi is approved at doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for use in obstructive sleep apnoea.

The FDA's approval was based on data from the Phase III TONES programme, which included four studies that demonstrated the superiority of Sunosi relative to placebo. In the trials, at week 12, the highest dose of Sunosi for narcolepsy patients and all doses for those with obstructive sleep apnoea demonstrated improvements in wakefulness compared to placebo as assessed by the maintenance of wakefulness test at approximately one hour post-dose through to around nine hours post-dose.

Commenting on the approval, Daniel Swisher, chief operating officer of Jazz, said "we are pleased with the information included in the Sunosi label as we believe it will give physicians the information needed to appropriately manage the vast majority of obstructive sleep apnea and narcolepsy patients with excessive daytime sleepiness." Jazz licensed rights to Sunosi from Aerial Biopharma in 2014, while SK Biopharmaceuticals, which discovered the compound, maintains rights in 12 Asian markets, including Korea, China and Japan.

RBC Capital Markets analyst Randall Stanicky said that Sunosi "is expected to be an important driver of both diversification and growth" for Jazz, forecasting that the product will generate sales of $314 million by 2024.

The approval of Sunosi comes as Jazz looks to reduce its reliance on its narcolepsy drug Xyrem (sodium oxybate), which generated sales of $1.4 billion in 2018 and accounted for about 70 percent of the company's revenue. Last year, a US appeals court invalidated patents covering Xyrem, with Jazz later reaching a deal allowing Amneal Pharmaceuticals to launch a generic version of the drug in 2023.

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