MerLion Pharma (Germany)

<title>Abstract</title> Background Nigeria has adopted comprehensive tobacco control legislation, including the National Tobacco Control Act (NTCA) 2015 and Tobacco Control Regulations 2019, yet continues to experience high tobacco-related morbidity and a substantial illicit cigarette market. Institutional fragmentation and weak enforcement capacity, compounded by evolving obligations under the WHO Framework Convention on Tobacco Control (FCTC) and the Protocol to Eliminate Illicit Trade in Tobacco Products, undermine effective implementation. Methods A desk-based qualitative policy and regulatory analysis was conducted using three complementary approaches: (1) comparative legal mapping of Nigeria's tobacco control framework against core WHO FCTC and Illicit Trade Protocol obligations; (2) thematic synthesis of WHO guidance, treaty decisions, and peer-reviewed evidence on institutional arrangements for tobacco regulation; and (3) an implementation-readiness assessment of the National Agency for Food and Drug Administration and Control (NAFDAC) across key capacity domains. Results The analysis identified five interrelated structural gaps: fragmented institutional authority; absence of a central product regulator; weak supply-chain and illicit trade control; inadequate protection from tobacco industry interference; and a regulatory vacuum for emerging nicotine products. Nigeria's current ministry-led configuration constrains compliance with WHO FCTC Articles 9, 10, 11, and 15, while NAFDAC already possesses significant laboratory, port-of-entry, and digital traceability capacity developed through pharmaceutical regulation. Conclusion Reconfiguring Nigeria's tobacco control architecture to assign NAFDAC a central technical regulatory mandate, while retaining health policy stewardship within the Federal Ministry of Health (FMoH), offers a legally feasible and context-appropriate pathway to strengthen enforcement, meet evolving treaty expectations, and reduce tobacco-related harms.

PurposeExcessive daytime sleepiness (EDS) is a symptom experienced by patients with obstructive sleep apnea (OSA) that may persist despite primary CPAP therapy (residual EDS; rEDS). This study aimed to estimate the age- and gender-specific prevalence and incidence for CPAP-treated OSA patients that showed indicators of rEDS in health-related data. MethodsThis study used the InGef research database, an anonymized representative dataset of 4 million persons covered by statutory health insurance in Germany. OSA patients receiving CPAP therapy were analyzed and data indicators for rEDS, or with EDS not satisfactorily treated by primary OSA therapy, were identified using an expert-opinion based diagnostic scheme in two study cohorts: The objective of the first cohort was to estimate the 12-month prevalence and incidence of rEDS in OSA (study period: 2016). The second cohort investigates patient characteristics and health care utilization (study period: 2013–2018). Results1298 OSA patients with indicators of rEDS after initiation of CPAP therapy were identified, giving an overall prevalence estimate of 41.1 (95%-CI 38.9-43.4) per 100,000 persons in Germany. Of all CPAP-users, 6.4% were affected by rEDS. Annual incidence was estimated to be 6.4 (95%-CI 5.6-7.4) per 100,000 persons. In the year before CPAP treatment started, 46% received antidepressants, 45% were in psychotherapeutic treatment and 58% of employees were unable to work, on average for 71 days within one year. ConclusionPatients that were identified with indicators of residual EDS showed a high socioeconomic burden potentially leading to an increased demand of healthcare services and incapacity for work.