dm+d

38925811000001107

New Medicines

SunosiNarcolepsy-associated excessive daytime sleepiness (EDS)

Information

Sunosi
New molecular entity
Jazz Pharmaceuticals
Jazz Pharmaceuticals

Development and Regulatory status

Launched
Launched
Launched
September 2020
Yes
Sep 20Available in UK. 75mg yellow oblong scored tab marked 75, 28=£177.52 (hospital only); 150mg yellow oblong tab marked 150, 28=£248.64 (hospital only) [15].
Jan 20Approved in the EU [14].
Nov 19Recommended for EU approval by CHMP - the full indications are "to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy)." Also, "to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).” It is proposed that the drug be prescribed by physicians experienced in the treatment of sleep disorders [13].
Jul 19Launched in US [12].
Jun 19After receiving designation as a Schedule IV drug in the US, launch of solriamfetol (Sunosi) can go ahead early next month (Jul 2019). The company chairman and CEO stated "We are pleased that Sunosi has received a Schedule IV designation that aligns with our research demonstrating this medicine´s relatively low potential for abuse and risk of dependence" [11].
May 19Jazz Pharmaceuticals expects EU approval for hypersomnia (in narcolepsy or obstructive sleep apnoea) in Dec 19 [10].
Mar 19Approved in US [9].
Mar 19Jazz Pharmaceuticals anticipates US launch of solriamfetol in mid-2019 following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA) [10].
Nov 18MAA submitted to EMA for solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA)[8].
Feb 18EU filing planned late 2018 [7].
Dec 17NDA submitted to US FDA for excessive sleepiness associated with narcolepsy and obstructive sleep apnoea [6].
Sep 16US filing expected H2 17 [4].

Category

A selective dopamine and norepinephrine reuptake inhibitor (DNRI).
Prevalence is estimated as 25 per 100,000 in Caucasian populations. Age of onset is typically around adolescence. A smaller number of cases presents at around 35 years. Less than 5% of narcolepsy with cataplexy occurs in children. One study found that it was often linked to complex movement disorders. It is possible that incidence statistics would increase if diagnostic features were recognised at an earlier age [1].
Narcolepsy-associated excessive daytime sleepiness (EDS)
Oral

Further information

Yes

Trial or other data

Jun 17Topline results of the TONES-2 study presented as a conference poster - they showed dose-related improvements in both co-primary endpoints (mean sleep latency and the Epworth Sleepiness Scale, ESS), with p<0.0001 for 150 mg and 300 mg doses; improvement with 75 mg dose was statistically significant (p<0.05) for ESS only. The higher doses also showed statistically significant improvement in the main secondary outcome. JZP-110 was generally well tolerated [5]
May 15Jazz Pharmaceuticals initiates a PIII TONES-002 study to evaluate safety and efficacy of JZP 110 for treatment of EDS in patients with narcolepsy (NCT02348593). The 12-week, randomised, double-blind, placebo-controlled, 4-treatment parallel group study is designed to enrol approximately 240 patients in the US, Canada, Finland and Germany. Primary outcome is change in mean sleep latency time (in minutes) as determined from the first four trials of a 40-minute MWT from Baseline to Week 12. Collection of primary outcome data expected Sep 16 [2,3].

Evidence based evaluations

SunosiObstructive sleep apnoea syndrome (OSAS)-associated excessive daytime sleepiness (EDS)

Information

Sunosi
New molecular entity
Jazz Pharmaceuticals
Jazz Pharmaceuticals

Development and Regulatory status

Launched
Launched
Launched
Launched
Sep 20Available in UK. 75mg yellow oblong scored tab marked 75, 28=£177.52 (hospital only); 150mg yellow oblong tab marked 150, 28=£248.64 (hospital only) [14].
Jan 20Approved in the EU [13].
Nov 19Recommended for EU approval by CHMP - the full indications are "to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy)." Also, "to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).” It is proposed that the drug be prescribed by physicians experienced in the treatment of sleep disorders [12].
Jul 19Launched in US [11].
Jun 19After receiving designation as a Schedule IV drug in the US, launch of solriamfetol (Sunosi) can go ahead early next month (Jul 2019). The company chairman and CEO stated "We are pleased that Sunosi has received a Schedule IV designation that aligns with our research demonstrating this medicine´s relatively low potential for abuse and risk of dependence" [10].
May 19Jazz Pharmaceuticals expects EU approval for hypersomnia (in narcolepsy or obstructive sleep apnoea) in Dec 19 [9].
Mar 19Approved in US [8].
Mar 19Jazz Pharmaceuticals anticipates US launch of solriamfetol in mid-2019 following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA) [9].
Nov 18MAA submitted to EMA for solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with narcolepsy or obstructive sleep apnea (OSA) [7].
Feb 18EU filing planned late 2018 [7].
Dec 17NDA submitted to US FDA for excessive sleepiness associated with narcolepsy and obstructive sleep apnoea [6].
Sep 16US filing planned for H2 17 [4].

Category

A selective dopamine and norepinephrine reuptake inhibitor (DNRI).
The prevalence of OSAS in Western countries is around 4% in middle-aged men and around 2% in middle-aged women. Incidence is increasing as the incidence of obesity is increasing. OSAS is highly prevalent in persons with type 2 diabetes and related metabolic conditions such as insulin resistance and glucose intolerance [1].
Obstructive sleep apnoea syndrome (OSAS)-associated excessive daytime sleepiness (EDS)
Oral

Further information

Yes

Trial or other data

Mar 17Results of 2 PIII studies TONES 3 and TONES 4 (n=602) found JZP-110, showed statistically significant differences in co-primary efficacy endpoints of MWT and ESS vs. placebo [5].
Sep 16Jazz Pharmaceuticals completes enrolment in a PIII randomised, double-blind, withdrawal trial that is assessing safety and efficacy of JZP-110, in the treatment of excessive daytime sleepiness (EDS) in patients with sleep apnoea syndrome (NCT02348619). The trial is a six-week, flexible-dose study. Maintenance of wakefulness test (MWT) and change in the Epworth sleepiness scale (ESS), assessed at six weeks, is the defined co-primary endpoint of the trial. Both are validated endpoints that measure severity of excessive sleepiness and ability to stay awake in patients. The trial has enrolled 200 patients in the US, Finland, France, Germany, and Sweden [3].
Sep 16Another open-label PIII trial is assessing long-term safety and maintenance of efficacy of JZP 110 in 450 patients with narcolepsy and sleep apnoea syndrome in the US, Canada, Finland and Germany (NCT02348632; EudraCT2014-005489-31) [3].
Sep 16Jazz Pharmaceuticals completes enrolment in the PIII (NCT2348606) study, and collection of primary outcome data. It has assessed four doses of JZP 110 or placebo over a 12-week period [2,3].
May 15PIII study evaluating safety and efficacy of JZP 110, for treatment of excessive sleepiness in adult patients with obstructive sleep apnoea (OSA) syndrome (NCT02348606; EudraCT2014-005514-31) starts.. Maintenance of wakefulness test (MWT) and change in the Epworth sleepiness scale (ESS), assessed at six weeks, is the defined co-primary endpoint of the trial. Both are validated endpoints that measure severity of excessive sleepiness and ability to stay awake in patients. The double-blind, placebo-controlled, multiple-centre trial will enrol 440 patients in the US, Canada and Germany [2].

Evidence based evaluations