Dr. Willmar Schwabe GmbH and Co. KG

Karlsruhe, Germany

Dr. Willmar Schwabe GmbH and Co. KG

Karlsruhe, Germany
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Dranov A.,Dr. Willmar Schwabe GmbH and Co. KG
Pharmazeutische Industrie | Year: 2015

Since the early 1990s, new countries emerging from the former Soviet Union have increasingly attracted an attention of major players in the business worldwide, but especially that of the European pharmaceutical industry. Since Russia, among others, is considered one of the most attractive emerging markets, this work is focused primarily on comparing the Russian regulatory activities with the European Union (EU) regulatory framework. A distinct trend has been identified in the evolution of regulatory legislation here: Russia continues on their own path, partly influenced by the heritage of the Soviet era. The history and current development of regulatory legislation, steps of the marketing authorization applications, presentation and format of the dossier (with focus on the quality part) are extensively elaborated. Some other aspects specific to the regulatory activities, such as non-clinical and clinical requirements to the dossier, requests for clinical trial authorisations (CTA), GMP inspections and pharmacovigilance have not been covered exhaustively but are touched upon where relevant. The scope of this work includes not only the initial marketing authorisation applications, but also basic principles of the life-cycle activities. Additionally, new legal initiatives and trends are briefly demonstrated. The paper concludes with recommendations to EU-based pharmaceutical companies with points of interest in Russia. © ECV -Editio Cantor Verlag, Aulendorf (Germany).


Edwards D.,White House Surgery | Heufelder A.,Am Kosttor 1 | Zimmermann A.,Dr Willmar Schwabe GmbH and Co. KG
Phytotherapy Research | Year: 2012

The trial was conducted to investigate the therapeutic effects and safety of 4 week treatment with Rhodiol rose extract WSA® 1375 in subjects with life-stress symptoms. This was multicentre, non-randomized, open-label, single-arm trial. One hundred and one subjects were enrolled in this clinical study and received the study drug at dose of 200 mg twice daily for 4 weeks. Assessments with seven questionnaires included Numerical Analogue Scales of Subjective Stress Symptoms, Perceived Stress Questionnaire, Multidimensional Fatigue Inventory 20, Numbers Connecting Test, Sheehan Disability Scale and Clinical Global Impressions to cover various aspects of stress symptoms and adverse events. Invariably, all tests showed clinically relevant improvements with regard to stress symptoms, disability, functional impairment and overall therapeutic effect. Improvements were observed even after 3 days of treatment, as were continuing improvements after 1 and 4 weeks. Rhodiol rose extract WSA® 1375 was safe and generally well tolerated. Adverse events were mostly of mild intensity and no serious adverse events were reported. Rhodiol extract at dose of 200 mg twice daily for 4 weeks is safe and effective in improving life-stress symptoms to clinically relevant degree. Copyright © 2012 John Wiley & Sons, Ltd.


Gavrilova S.I.,Russian Academy of Medical Sciences | Preuss U.W.,Hospital Prignitz | Wong J.W.M.,Hospital Prignitz | Hoerr R.,Dr. Willmar Schwabe GmbH and Co. KG | And 2 more authors.
International Journal of Geriatric Psychiatry | Year: 2014

Conclusions: EGb 761 improved NPS and cognitive performance in patients with MCI. The drug was safe and well tolerated.Objective: The study was conducted to explore the effects of EGb 761® (Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) on neuropsychiatric symptoms (NPS) and cognition in patients with mild cognitive impairment (MCI).Methods: One hundred and sixty patients with MCI who scored at least 6 on the 12-item Neuropsychiatric Inventory (NPI) were enrolled in this double-blind, multi-center trial and randomized to receive 240 mg EGb 761 daily or placebo for a period of 24 weeks. Effects on NPS were assessed using the NPI, the state sub-score of the State-Trait Anxiety Inventory and the Geriatric Depression Scale. Further outcome measures were the Trail-Making Test (A/B) for cognition and global ratings of change. Statistical analyses followed the intention-to-treat principle.Results: The NPI composite score decreased by 7.0 ± 4.5 (mean, standard deviation) points in the EGb 761- treated group and by 5.5 ± 5.2 in the placebo group (p =0.001). Improvement by at least 4 points was found in 78.8% of patients treated with EGb 761 and in 55.7% of those receiving placebo (p= 0.002). Superiority of EGb 761 over placebo (p<0.05) was also found for the State-Trait Anxiety Inventory score, the informants' global impression of change, and both Trail-Making Test scores. There were statistical trends favoring EGb 761 in the Geriatric Depression Scale and the patients' global impression of change. Adverse events (all non-serious) were reported by 37 patients taking EGb 761 and 36 patients receiving placebo. Copyright © 2014 John Wiley & Sons, Ltd.


Rainer M.,Institute For Gedachtnis Und Alzheimer Forschung | Mucke H.,H.M. Pharma Consultancy | Schlaefke S.,Dr. Willmar Schwabe GmbH and Co. KG
Wiener Klinische Wochenschrift | Year: 2013

Objective We used efficacy data from three clinical trials to investigate the pharmacoeconomic implications of treating noninstitutionalized Austrian dementia patients with a drug based on EGb 761®, a standardized extract from Gingkgo biloba. In a separate analysis, we compared the pharmacoeconomic aspects of achieving treatment success with EGb 761® and cholinesterase inhibitors. Methods A fixed-effect model was used to conduct a metaanalysis of activities of daily living data from 1,201 patients diagnosed with dementia and treated with either EGb 761® (240 mg/day) or matched placebo for 22 or 24 weeks under double-blind conditions. From this analysis, the delay in activities of daily living (ADL)-based disease progression was estimated. Current Austrian drug reimbursement prices, physician fees, and federal subsidies for seven stages of home care were applied to calculate overall costs in four scenarios. For the comparison with cholinesterase inhibitors, metaanalysis data pertaining to overall clinical impression as published by the Cochrane Group were compared to corresponding data from our EGb 761® studies. Results and discussion The benefit of treatment with EGb 761® (240 mg/day) corresponds to a delay in ADL deterioration by 22.3 months compared to placebo. Overall net savings with EGb 761® treatment ranged fromEUR 3,692 to EUR 29,577, mainly driven by delays in progression towards higher home care subsidies. For one additional therapy success with EGb 761?, EUR 530.88 was required. In a tentative cost comparison, cholinesterase inhibitors required higher expenses to achieve treatment success. © 2012 Springer-Verlag Wien.


Koch E.,Dr. Willmar Schwabe GmbH and Co. KG | Malek F.A.,Dr. Willmar Schwabe GmbH and Co. KG
Planta Medica | Year: 2011

Extracts from different parts of hawthorn plants (Crataegus spp.) are used worldwide for the treatment of cardiovascular diseases. So far, almost all clinical studies have been conducted with standardized hydroalcoholic extracts from leaves and flowers. These trials with more than 4000 patients have provided evidence for clinical benefits in the therapy of mild chronic heart failure. Besides cardiotonic effects, recent pharmacological investigations indicate that hawthorn extracts also possess cardio- and vasoprotective properties. Thus, these extracts may also be employed in the prophylactic and therapeutic treatment of such conditions as endothelial dysfunction, atherosclerosis, coronary heart disease, or prevention of restenosis/reocclusion following peripheral endovascular treatment. In this review the pharmacological and clinical data relating to these standardized extracts are summarized. © Georg Thieme Verlag KG Stuttgart - New York.


Kasper S.,Medical University of Vienna | Gastpar M.,Fliedner Klinik Berlin | Muller W.E.,Goethe University Frankfurt | Volz H.-P.,Hospital for Psychiatry | And 3 more authors.
International Journal of Neuropsychopharmacology | Year: 2014

The anxiolytic efficacy of the orally administered lavender oil preparation Silexan was investigated in generalized anxiety disorder (GAD) in comparison to placebo and paroxetine. In this randomized, double-blind, double-dummy trial 539 adults with GAD according to DSM-5 criteria and a Hamilton Anxiety Scale (HAMA) total score '©'18 points participated and received 160 or 80 mg Silexan, 20 mg paroxetine, or placebo once daily for 10 wk. The primary efficacy endpoint was the HAMA total score reduction between baseline and treatment end. The HAMA total score decreased by 14.1 ± 9.3 points for Silexan 160 mg/d, 12.8 ± 8.7 points for Silexan 80 mg/d, 11.3 ± 8.0 points for paroxetine, and 9.5 ± 9.0 points for placebo (mean ± s.d.). Silexan 160 and 80 mg/d were superior to placebo in reducing the HAMA total score (p < 0.01) whereas paroxetine showed a trend towards significance (p = 0.10) in the full analysis set. The difference between paroxetine and placebo was more pronounced in the analysis of observed cases (HAMA total score reduction: p < 0.01). In the Silexan 160 mg/d group 73/121 patients (60.3%) showed a HAMA total score reduction '©'50% of the baseline value and 56 (46.3%) had a total score <10 points at treatment end, compared to 70/135 (51.9%) and 45 (33.3%) for Silexan 80 mg/d, 57/132 (43.2%) and 45 (34.1%) for paroxetine, and 51/135 (37.8%) and 40 (29.6%) for placebo. In addition, Silexan showed a pronounced antidepressant effect and improved general mental health and health-related quality of life. Incidence densities of adverse events (AEs) were 0.006 AEs/d for Silexan 160 mg/d, 0.008 AEs/d for 80 mg/d, 0.011 AEs/d for paroxetine, and 0.008 AEs/d for placebo. In GAD Silexan is more efficacious than placebo. AE rates for Silexan were comparable to placebo and lower than for the active control paroxetine. © CINP 2014.


Kasper S.,Medical University of Vienna | Anghelescu I.,Privat Nerven Klinik Dr. med. Kurt Fontheim | Dienel A.,Dr. Willmar Schwabe GmbH and Co. KG
European Neuropsychopharmacology | Year: 2015

The anxiolytic effect of Silexan, a patented active substance with an essential oil produced from Lavandula angustifolia flowers, was investigated in patients with anxiety-related restlessness and disturbed sleep. 170 out-patients with a diagnosis of restlessness (ICD-10 R45.1), a Hamilton Anxiety Scale (HAMA) total score ≥18 points and ≥2 points for HAMA items 'Tension' and 'Insomnia' participated in this randomized, double-blind trial and received 80 mg Silexan or placebo once daily for 10 weeks. Patients with clinically important other psychiatric or neurological disorders potentially interfering with the assessment of treatment efficacy were excluded. Outcome variables were the HAMA as well as the Pittsburgh Sleep Quality Index (PSQI), the Zung Self-rating Anxiety Scale, a State Check inventory and the Clinical Global Impressions questionnaire. In the Silexan group the HAMA total score decreased from an average of 25.5±6.0 points at baseline to 13.7±7.0 points at treatment end, compared to a decrease from 26.5±6.1 to 16.9±9.8 for placebo, corresponding to decreases of 12.0 and 9.3 points (marginal means), respectively (group difference: p=0.03, ANCOVA with factor treatment and baseline value as covariate). In all outcome measures the treatment effect of Silexan was more pronounced than with placebo. According to the HAMA, 48.8% and 33.3% of the patients were responders (Silexan, placebo; reduction ≥50%; p=0.04) and 31.4% and 22.6% achieved remission (HAMA<10; p=0.20). 33.7% (Silexan) and 35.7% (placebo) of the participants reported adverse events. The study confirms the calming and anxiolytic efficacy of Silexan. © 2015 Elsevier B.V. and ECNP.


Gauthier S.,McGill University | Schlaefke S.,Dr Willmar Schwabe GmbH and Co. KG
Clinical Interventions in Aging | Year: 2014

The objective of this systematic review was to evaluate current evidence for the efficacy of Ginkgo biloba extract EGb 761® in dementia. Seven of 15 randomized, placebo-controlled trials in patients with dementia identified by database searches met all our selection criteria and were included in the meta-analysis. In these trials, patients were treated with 120 mg or 240 mg per day of the defined extract EGb 761 or placebo. Efficacy was assessed using validated tests and rating scales for the cognitive domain, the functional domain (activities of daily living), and global assessment. Tolerability was evaluated by risk differences based on incidences of adverse events and premature discontinuation rates. Of 2,684 outpatients randomized to receive treatment for 22–26 weeks, 2,625 represented the full analysis sets (1,396 for EGb 761 and 1,229 for placebo). Standardized mean differences for change in cognition (-0.52; 95% confidence interval [CI] -0.98, -0.05; P=0.03), activities of daily living (-0.44; 95% CI -0.68, -0.19; P<0.001), and global rating (-0.52; 95% CI -0.92, -0.12; P=0.01) significantly favored EGb 761 compared with placebo. Statistically significant superiority of EGb 761 over placebo was confirmed by responder analyses as well as for patients suffering from dementia with neuropsychiatric symptoms. Treatment-associated risks in terms of relative risks of adverse events and premature withdrawal rates did not differ noticeably between the two treatment groups. In conclusion, meta-analyses confirmed the efficacy and good tolerability of Ginkgo biloba extract EGb 761 in patients with dementia. © 2014 Gauthier and Schlaefke.


Kasper S.,Medical University of Vienna | Volz H.-P.,Hospital for Psychiatry | Dienel A.,Dr. Willmar Schwabe GmbH and Co. KG | Schlafke S.,Dr. Willmar Schwabe GmbH and Co. KG
European Neuropsychopharmacology | Year: 2016

Mixed anxiety and depressive disorder (MADD; ICD-10 F41.2) is a condition characterized by subsyndromal symptoms of anxiety and depression, neither of which are clearly predominant. Silexan has been demonstrated to be efficacious in subsyndromal and syndromal anxiety disorders and co-morbid depressive symptoms. In this study 318 adult out-patients with MADD according to ICD-10 criteria, a total score ≥18 points on the Hamilton Anxiety Rating Scale (HAMA), and at least moderately severe anxious and depressed mood were randomized and received 1×80 mg Silexan or placebo in double-blind fashion for a scheduled period of 70 days. Primary outcome measures were the HAMA and Montgomery Åsberg Depression Rating Scale (MADRS) total score changes between baseline and treatment end. The HAMA total score decreased by 10.8±9.6 points for Silexan and by 8.4±8.9 points for placebo (treatment group difference: p<0.01, one-sided; ANCOVA with factors for treatment and centre and the baseline value as covariate), and total score decreases of 9.2±9.9 and 6.1±7.6 points, respectively, were observed for the MADRS (p<0.001). Compared to placebo, the patients treated with Silexan had a better over-all clinical outcome and showed more pronounced improvements of impaired daily living skills and health related quality of life. Eructation was the only adverse event with a substantially higher incidence under Silexan. The study thus demonstrates that Silexan is efficacious and safe in the treatment of MADD. © 2015 Elsevier B.V. and ECNP.


Oelke M.,Hannover Medical School | Berges R.,PAN Klinik | Schlafke S.,Dr. Willmar Schwabe GmbH and Co. KG | Burkart M.,Dr. Willmar Schwabe GmbH and Co. KG
World Journal of Urology | Year: 2014

Purpose: To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride.Methods: The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted.Results: We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ2-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates.Conclusion: PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride. © 2014, Springer-Verlag Berlin Heidelberg.

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