Merz Pharmaceuticals LLC

Greensboro, NC, United States

Merz Pharmaceuticals LLC

Greensboro, NC, United States
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Sethi K.D.,University of Georgia | Sethi K.D.,Merz Pharmaceuticals LLC | Rodriguez R.,University of Florida | Olayinka B.,Merz Pharmaceuticals LLC
Journal of Medical Economics | Year: 2012

Objective: Botulinum toxin is widely utilized as a first-line therapy for cervical dystonia (CD). Numerous studies have demonstrated the efficacy and safety of this treatment, but little data exist on patient satisfaction. To address this question, a structured patient survey was conducted in Germany, France, the US, and Canada (n=136 patients with CD). Methods: Specific information was collected on the patients' current and prior botulinum toxin treatment cycles and their overall quality-of-life (including completion of the Cervical Dystonia Impact Profile-58 [CDIP-58]). Results: Patients rated the mean onset of action for their previous injection as 3.8 days, with peak effect at 3.6 weeks and a decline in effects at 9.5 weeks. While most patients were satisfied with their current therapy, only 50.7% were very satisfied, 42.6% were somewhat satisfied, and 6.6% not at all satisfied with their current therapy. Patient satisfaction was lowest just prior to injection and highest at the time of peak effect. Approximately 45% of patients reported that they would prefer a treatment cycle of ≤10 weeks. The mean patient rating of current state of health was above 50 on a visual analog scale from 0 (low) to 100 (high). CDIP-58 results indicated that patients continued to have symptoms on all domains. Conclusions: Botulinum toxin is generally very effective for the treatment of CD. However, this survey indicates that patient satisfaction typically declines prior to re-injection, and many patients may prefer an injection interval of less than the standard 12 weeks. While the survey was based on subjective patient recollections, and the degree to which patient satisfaction is attributable to the control of neurological symptoms remains unclear, prospective studies are clearly warranted to confirm the time course of patient satisfaction and to determine the optimal treatment parameters with botulinum toxins. © 2012 Informa UK Ltd All rights reserved.


Draelos Z.D.,Duke University | Baumann L.,Bauman Cosmetic and Research Institute | Fleischer Jr. A.B.,Merz Pharmaceuticals LLC | Plaum S.,Merz Pharmaceuticals LLC | And 2 more authors.
Journal of Clinical and Aesthetic Dermatology | Year: 2012

Objective: This randomized, controlled, single-blind study evaluated the appearance of new dermal scars after eight weeks of once-daily application of a nonprescription proprietary onion extract gel formulation compared to control (no application scars) in a dermatological surgical setting. Methods: At Visit 1, 44 healthy male and female subjects aged 18 to 70 years gave informed consent, were screened, and enrolled in the study. Two bilateral, 8mm seborrheic keratoses, one on the right and one on the left chest, were surgically removed from each subject. The wounds were photographed at all visits. Two weeks later (Visit 2), each subject was randomly assigned to apply onion extract gel to either the right or left side wound site once daily for eight weeks and no treatment on the opposite wound. The investigator was blinded to which wound was treated. At two, four, and eight weeks after gel application, right and left scars were graded by the investigator and subjects for improvement from baseline in overall appearance, texture, redness, and softness using 4-point ordinal scales (0=no improvement, 1=mild improvement; 2= moderate improvement; 3=significant improvement). Safety was evaluated by adverse events. Results: Six subjects (13.6%) experienced mild stinging that resolved spontaneously. At two weeks, the subjects rated gel-applied scars to be significantly softer than control scars (p=0.014). After four and eight weeks of application, the investigator and subjects rated all appearance variables of the gel-applied scars to be significantly more improved from baseline than control scars (p=0.017 to p<0.01). Conclusion: The new proprietary onion extract gel is safe and significantly improves scar appearance after four weeks of once-daily application.


Plaum S.,Merz Pharmaceuticals LLC | Verma A.,Merz Pharmaceuticals LLC | Fleischer Jr. A.B.,Merz Pharmaceuticals LLC | Olayinka B.,Merz Pharmaceuticals LLC | Hardas B.,Merz Pharmaceuticals LLC
Journal of Drugs in Dermatology | Year: 2013

Background: Two-week treatment using naftifine cream or gel, 2% has been shown to be efficacious in subjects with Tinea pedis and/ or Tinea cruris, and in most cases, continued improvement has been observed following cessation of treatment for up to four weeks. One possible explanation for continuous post-treatment improvement is drug-levels remaining in the stratum corneum (SC) as a function of time. Objective: The objective is to use tape stripping methodology to assess the amount of drug available in the SC over a 28 day period following the last dose. Methods: This was an open-label, single-exposure study on subjects comparing the amount of drug that was absorbed into the SC following topical application for 2-weeks. Twelve subjects were dosed daily (6 with naftifine cream, 2% and 6 with naftifine gel, 2%). Subjects had twelve 8 cm2 test application sites demarcated on the upper back. Twenty-five individual sequential strips were obtained from each test site. Of these, 11 sites were dosed once daily with the drug (5.0μL/cm2) for days 1 to 14 and the final site served as the control. On days 15, 29, and 43, a site was stripped to collect the SC in order to process the amount of drug present. Results: Naftifine was present on all tape strip samples collected over the 28 day period following two weeks of application. Furthermore, the most relevant, deeper tape strip sets reflecting the SC, showed potentially clinically relevant presence of naftifine in the skin for 28-days post-treatment. Conclusions: Naftifine was present in the tape strips on all sample collection days up to and including four weeks following the last drug application. These findings help explain the progressive improvement in clinical and mycological response rates during the treatment period and for up to four weeks post-treatment in the clinical trials using naftifine. Copyright © 2013.


Baizabal-Carvallo J.F.,Baylor College of Medicine | Jankovic J.,Baylor College of Medicine | Pappert E.,Merz Pharmaceuticals LLC
Toxicon | Year: 2011

This paper reviews the relevant literature on flu-like symptoms (FLS) in patients treated with botulinum toxin (BoNT) type A and B. We conducted a systematic search in PubMed and Medline of publications on BoNT and FLS. FLS were defined as the presence of symptoms of an upper respiratory tract infection associated with fever, general malaise or fatigue, within one month after BoNT injections and not secondary to any other identified condition.FLS have been reported in between 1.7 and 20% of patients treated with various preparations of BoNT/A. Most patients have a mild to moderate symptoms lasting less than 2 weeks, but 66 serious AEs related to FLS were reported to the Food and Drug Administration between 1989 and 2003. No significant differences in the frequency of FLS have emerged when different BoNT/A commercial products were compared, although no well-designed head-to-head comparison trials focusing on FLS have been published. For BoNT/B preparations, FLS have been reported in 5-55% of cases. We concluded that the frequency of FLS in patients treated with BoNT/A and BoNT/B varies widely between studies and no clear risk factors have been identified for this complication. We suggest potential treatments like analgesics/antipyretics or switching to less antigenic preparations in case of persistent symptoms. © 2011 Elsevier Ltd.


Patent
Merz Pharmaceuticals LLC | Date: 2014-06-05

The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.


Patent
Merz Pharmaceuticals LLC | Date: 2015-09-17

The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.


Patent
Merz Pharmaceuticals LLC | Date: 2015-12-18

The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.


Patent
Merz Pharmaceuticals Llc | Date: 2014-01-31

The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.


Patent
Merz Pharmaceuticals LLC | Date: 2013-07-12

The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.


Patent
Merz Pharmaceuticals Llc | Date: 2013-01-31

The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.

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