Pitolisant (Ozawade, 1) – Ozawade®
Daytime sleepiness in obstructive sleep apnea, after previous therapy
Characteristics
| Start date | 01.11.2021 – Marketing authorisation: 22.07.2021 |
|---|---|
| Resolution | 21.04.2022 |
| INN | Pitolisant |
| Brand name | Ozawade® |
| Pharm. company | Bioprojet Deutschland GmbH |
| G-BA Procedure ID | D-740 |
| ATC code | N07XX11 Other nervous system drugs (N07XX) |
| ICD-10 codes (AIS) | G47.31Idiopathic central sleep apnea, R40.0Somnolence |
| Alpha-ID codes (AIS) | I20827Drowsiness, I28154Obstructive sleep apnea |
| DDD | 18 mg O |
| Therapeutic area | Nervous system diseases Obstructive sleep apnea (OSA), Sleep disorders / Insomnia / Excessive daytime sleepiness (EDS) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
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). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Ozawade is used to improve wakefulness and reduce excessive daytime sleepiness in adult patients with obstructive sleep apnoea (OSA) whose excessive daytime sleepiness (EDS) has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP) ventilation, or when such therapy has not been tolerated. | An optimised standard therapy for underlying obstructive sleep apnoea (OSA) |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (HAROSA I, HAROSA II) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT (off-label) |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- HAROSA I was a randomised, double-blind, placebo-controlled trial involving adults aged between 18 and 75 years who had been diagnosed with OSA.
- The design of HAROSA II largely corresponds to that of the HAROSA I study; however, this study included patients (n = 268) who refused CPAP therapy and had an apnoea-hypopnoea index of ≥ 15/h.
Adults with excessive daytime sleepiness due to obstructive sleep apnoea (OSA), whose excessive daytime sleepiness could not be satisfactorily managed by primary OSA treatment, such as CPAP therapy, or where such treatment was not tolerated
- For adults with excessive daytime sleepiness due to obstructive sleep apnoea (OSA), whose excessive daytime sleepiness could not be satisfactorily managed by primary OSA therapy, such as CPAP therapy, or where such therapy was not tolerated, an additional benefit is not proven.
- Overall, there are no data available that are suitable for assessing the additional benefit.
- An additional benefit is therefore not proven.
- Morbidity – change in ESS score (Epworth Sleepiness Scale)
- Endpoints recorded included, amongst others, the change in the ESS score, other morbidity endpoints and side effects.
- Overall assessment
- Overall, there are no data available that are suitable for assessing the additional benefit. The additional benefit of pitolisant in the therapeutic indication of excessive daytime sleepiness due to obstructive sleep apnoea (OSA) in adults whose excessive daytime sleepiness could not be satisfactorily managed by primary OSA therapy, such as CPAP therapy, or where such therapy was not tolerated, it is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Pitolisant (Ozawade, 1) | Ozawade® | Bioprojet Deutschland GmbH | Daytime sleepiness in obstructive sleep apnea, after previous therapy | 200,000–400,000 | 100% additional benefit not proven |
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