dm+d

33474111000001103

Lactation Safety Information

Dexamfetamine
No published evidence of safety
3 January 2018

New Medicines

OzawadeTo improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).

Information

Ozawade
New formulation with new indication
Bioprojet
Harmony Biosciences

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
None
Sep 21Approved in the EU [12].
Sep 21Approved by MHRA for the same indication and formulations as per the EU [11].
May 21Recommended for EU approval by CHMP – the full indication is ‘Ozawade is indicated 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, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP)’. Ozawade will be available as 4.5 mg and 18 mg film-coated tablets [10].
Jan 21Is currently pre-registration in the EU with a decision expected in March 2021 [9].

Category

An inverse agonist of histamine receptor type 3.
OSA is estimated to affect 4% of middle-aged men, and 2% of middle-aged women. It is strongly associated with obesity, and incidence increases in older age groups, hence prevalence has increased over the past two decades and is likely to continue to rise [1].
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, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).
Oral

Further information

Yes

Trial or other data

Apr 20PIII HAROSA 3 trial completes. It enrolled 389 patients with moderate to severe OSA who refused nCPAP therapy or were treated by nCPAP but still complaining of EDS in Bulgaria and Macedonia [8].
Nov 18Bioprojet re-initiated the PIII HAROSA III trial (NCT02739568). It is due to complete in Feb 20 [7].
Nov 17Bioprojet withdraws the PIII HAROSA IV trial (NCT02978651) due to a strategic decision [5].
Jan 17The PIII HAROSA IV trial to demonstrate the efficacy and safety of pitolisant (10, 20 or 40 mg/day) for 12 weeks to treat the EDS in patients with OSA refusing the nCPAP therapy or treated by nCPAP but still complaining of EDS is due to start (NCT02978651). The secondary objectives of the study include evaluation of the long-term tolerance and maintenance of efficacy of pitolisant during 39 weeks of Open Label Extension period. The randomised, double-blind, parallel, placebo-controlled trial will enrol approximately 200 patients in France. It is due to complete in Jan 19 [5].
Oct 16Bioprojet completes the PIII HAROSA3 trial. This trial assessed the efficacy and safety of pitolisant (10, 20, or 40mg per day) versus placebo during 12 weeks for the treatment of excessive daytime sleepiness (EDS) (P1513/BF2.649; NCT02739568). The trial enrolled 202 patients with moderate to severe OSA who refused the nasal Continuous Positive Airway Pressure (nCPAP) therapy or were treated by nCPAP but still complaining of EDS [4].
Dec 15Both PIII studies, HAROSA1 (in patients treated with Continuous Positive Airway Pressure) and HAROSA2 (in patients who refused Continuous Positive Airway Pressure treatment) completed in 2014 [3].
Aug 11PIII HAROSA1 study (NCT01071876) begins. The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo. The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy. It will recruit 244 pts in France, & is due to complete Mar 14 [2].

Evidence based evaluations