Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0917801 (insomnia)
 10,606 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The objective of this open-label, randomized, multicenter study was to compare the efficacy and safety of fleroxacin, 400 mg administered orally once daily, and amoxicillin/clavulanate potassium (AMX/CP), 500 mg/125 mg administered orally three times daily, for 4-21 days to patients with skin and soft tissue infections (SSTIs). The specific diagnoses in both groups were primarily skin abscess, impetigo, and skin ulcer, as well as wound infection erysipelas, folliculitis, cellulitis, and lymphangitis. A total of 285 patients were randomized to treatment in a 2:1 ratio, 190 in the fleroxacin group and 95 in the AMX/CP group. Adult male or female inpatients or outpatients were included in the trial and were followed up after 3-5 days of therapy and 3-9 days after completion of therapy for assessment of bacteriologic, clinical, and safety parameters. The most frequently isolated pathogen in both treatment groups was Staphylococcus aureus. Bacteriologic cures were observed in 87 (76%) of 115 evaluable patients in the fleroxacin group and in 41 (72%) of 57 evaluable patients in the AMX/CP group. Clinical cure was seen in 86 (75%) of 114 patients in the fleroxacin group and 45 (79%) of 57 patients in the AMX/CP group. Clinical adverse events related to the trial medication were reported by 40 (21%) of 189 patients in the fleroxacin group and by 16 (17%) of 95 patients in the AMX/CP group. In both groups, most adverse events were mild or moderate in severity and involved the digestive system (primarily diarrhea, nausea, and vomiting). In the fleroxacin group, adverse events affecting the central nervous system (mainly dizziness, insomnia, somnolence) also were reported. In this study, both fleroxacin and amoxicillin/clavulanate potassium were effective and well tolerated in the treatment of skin and soft tissue infections.
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PMID:Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections. 845 74

Magainin is developing MSI-78, a 22-amino acid peptide, based on compounds discovered in frog skin, as a topical anti-infective. It has broad-spectrum activity, covering Gram-positive and -negative bacteria, anaerobic bacteria and Candida albicans. The compound also has potential for the treatment of impetigo and healing wounds with various infections. In July 1998, Magainin filed an NDA with the US FDA for the treatment of infections in diabetic foot ulcers [292671]. It expects to launch the drug during the second quarter of 1999 [275844]. A completed pivotal, 584 patient, phase III trial demonstrated statistical equivalence between MSI-78 and orally-administered ofloxacin, for the treatment of infection in diabetic foot ulcers. MSI-78 was comparable to ofloxacin with respect to the primary endpoint of clinical response of infection at day ten of treatment, and at subsequent time points through to day 28, and at follow-up [220339]. These data were confirmed by the company's second phase III trial for the same indication, for which successful results were announced in March 1997 [239274]. Additional data from this second trial, presented at the 37th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), demonstrated that both drugs were comparable in terms of eradication rate of individual organisms and wound healing [264410]. Between 10% and 15% of wounds in patients treated with a combination of both drugs reached closure within four weeks. After six weeks, the closure rate increased to between 18% and 30%. This suggested that additional studies should be performed to evaluate the wound-healing effects further [275279]. The side-effects of both treatments were well-tolerated, although treatment with ofloxacin was associated with a significant excess of insomnia compared to MSI-78 [275844]. Further phase III trials are planned for treatment of surgical wounds, decubitus ulcers, venous stasis ulcers and infections associated with burns [173293]. The primary clinical endpoint is the cure of the infection and the secondary endpoint is the eradication of the organism. The first study has enrolled approximately 400 patients [195065]. The drug was also being developed for impetigo, but proved no better than placebo in phase III trials for the treatmentprimarily because 75% of controls showed clinical improvement as a result of better hygiene [293751]. Magainin is attempting to develop a recombinant process for commercial synthesis of MSI-78 to allow it to compete on price with conventional antibiotics [174944], [176153]. Magainin has a contract with Abbott for the manufacture of the drug [174944]. In February 1997, Magainin entered into a development, supply and distribution agreement in North America with SmithKline Beecham (SB) for Cytolex [234035]. Magainin has retained all rights to the drug outside of North America [275844], although it has also signed an agreement with Ambalal Sarabhai Enterprises (ASE) to commercialize MSI-78 (as Cytolex) in India [274544], [275556]. Analysts estimate the potential revenues of this compound, including off-label usage is between $200 and $250 million in the US and up to half as much again outside the US [191231].
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PMID:MSI-78 Magainin Pharmaceuticals. 1846 1