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Positive study results in 298 patients with obstructive sleep apnea (OSA): Significant reduction of nocturnal breathing pauses with an oral investigational medicinal product after 15 weeks of treatment.

Hamburg, 11.03.2024 – Desitin, an expert in neurological and psychiatric therapeutics, reports positive study results from the FLOW study with 298 patients: Nocturnal breathing pauses in patients with obstructive sleep apnea (OSA) were significantly reduced, thus meeting the primary endpoint of the study. With these positive results, a reliable basis for the final clinical phase 3 development of the first oral treatment for OSA has been established. While OSA has serious health implications, only around a third of all patients use the gold standard therapy of Continuous Positive Airway Pressure (CPAP) long-term.1 There is a high medical need for alternative treatment options and the market for sleep apnea therapy is growing with currently about 425 million patients affected worldwide.2

Obstructive Sleep Apnea (OSA)

Background: Obstructive sleep apnea (OSA) is characterized by partial or complete obstruction of the upper airway during sleep and makes up over 90 % of all sleep-related breathing disorders.3 Worldwide, an estimated 425 million people between the ages of 30 and 69 are affected by at least a moderate form (apnea-hypopnea index [AHI] ≤ 15).2

The condition leads to repeated pauses in breathing during the night, resulting in sleep disturbances and insufficient oxygenation. During the day, patients are more likely to suffer from fatigue, impaired cognitive function, and a reduced quality of life.2 The long-term consequences can be more serious, with an increased risk of cardiovascular diseases (hypertension, stroke, heart attack) or diabetes.4 Despite the serious health risks, a recent study shows that OSA is significantly underdiagnosed.5

The standard therapy of CPAP is often rejected by patients or is not used over extended periods of time due to tolerability or application problems. A comprehensive meta-analysis found that around 34 % of patients do not use CPAP therapy adequately over the long-term.6 Other authors found even higher non-compliance rates.1 These results indicate a high medical need for new, effective, and patient-friendly treatment options.

“Further educational work and new treatment options are urgently needed. We are pleased to have achieved positive results in this emerging field and are working towards helping patients over the long-term” says Philipp Bloching, Managing Director and CEO of Desitin.

The FLOW study: Promising results for a new, effective, and patient-friendly pharmacological therapy for OSA

The FLOW study is a multicenter, randomized, double-blind Phase II study with 298 OSA patients, showing promising data for a future treatment alternative to CPAP and invasive surgery. A 15-week treatment phase with a systemic active ingredient achieved a significant reduction in the apnea-hypopnea index (AHI) in a representative study group, along with good tolerability.

“In light of these promising results from our study, we recognize the opportunity to develop a drug that can transform the growing obstructive sleep apnea market” said Philipp Bloching.

Desitin - working for the benefit of OSA patients

Desitin is a renowned German family-owned pharmaceutical company known for its high-quality products for treating epilepsy and Parkinson's disease. With a strong focus on research and development, Desitin has earned a reputation for providing patients with innovative and well-tolerated medicinal products that can sustainably improve the lives of those affected. The company always pursues the highest quality standards and is committed to the continuous development and optimisation of its products.


Desitin Arzneimittel GmbH
Kathrin Haase
Business Development Manager
Tel.: +49 40 59101-333
E-Mail: Kathrin.Haase@desitin.de

1 Qiao M, Xie Y, Wolff A, Kwon j. Long term adherence to continuous positive airway pressure in mild obstructive sleep apnea. BMC Pulm Med. 2023 Sep 1;23(1)320
2 Benjafield AV, Ayas NT, Eastwood PR, et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019;7(8):687-698.
3 AMWF S3-Leitlinie „Nicht erholsamer Schlaf/Schlafstörungen“: https://register.awmf.org/assets/guidelines/063-001l_S3_SBAS_2023-01_verlaengert_und_Hinweis_Teil-Aktualisierung.pdf. Accessed on 05.03.2024
4 Arzt M. Schlafbezogene Atmungsstörungen – Update 2021 [Sleep-disordered breathing-Update 2021]. Somnologie (Berl). 2022;26(2):111-124.
5 Balagny P, Vidal-Petiot E, Renuy A, et al. Prevalence, treatment and determinants of obstructive sleep apnoea and its symptoms in a population-based French cohort. ERJ Open Res. 2023;9(3):00053-2023.
6 Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016;45(1):43.