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Erschienen in: Drugs in R&D 2/2008

01.03.2008 | Adis R&D Profile

Faropenem Medoxomil

A0026, BAY 56-6854, BAY 566854, Faropenem Daloxate, SUN 208, SUN A0026

Erschienen in: Drugs in R&D | Ausgabe 2/2008

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Excerpt

Replidyne is developing faropenem medoxomil, the ester-type prodrug of faropenem, for the treatment of bacterial infections and respiratory tract infections, including acute exacerbations of chronic bronchitis (AECB), acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP). Faropenem medoxomil is also being developed for the treatment of tonsillitis, pharyngitis and otitis media in children. …
Literatur
4.
Zurück zum Zitat Forest Laboratories Inc, Replidyne Inc. Forest Laboratories Announces Termination of Agreement for Faropenem. Media Release: 6 Feb 2007. Available from URL: http://www.frx.com Forest Laboratories Inc, Replidyne Inc. Forest Laboratories Announces Termination of Agreement for Faropenem. Media Release: 6 Feb 2007. Available from URL: http://​www.​frx.​com
5.
Zurück zum Zitat Replidyne Inc, Forest Laboratories Holdings Ltd. Replidyne and Forest Laboratories Announce Faropenem Medoxomil Licensing Agreement. Media Release: 13 Feb 2006. Available from URL: http://www.replidyne.com Replidyne Inc, Forest Laboratories Holdings Ltd. Replidyne and Forest Laboratories Announce Faropenem Medoxomil Licensing Agreement. Media Release: 13 Feb 2006. Available from URL: http://​www.​replidyne.​com
8.
Zurück zum Zitat Replidyne Inc. Replidyne Submits New Drug Application (NDA) for Orapem(TM) (Faropenem Medoxomil) to U.S. Food and Drug Administration. Media Release: 9 Jan 2006. Available from URL: http://www.replidyne.com Replidyne Inc. Replidyne Submits New Drug Application (NDA) for Orapem(TM) (Faropenem Medoxomil) to U.S. Food and Drug Administration. Media Release: 9 Jan 2006. Available from URL: http://​www.​replidyne.​com
9.
Zurück zum Zitat Forest Laboratories Inc, Replidyne Inc. Replidyne and Forest Laboratories Announce FDA Acceptance for Review of New Drug Application for Oral Antibiotic Faropenem Medoxomil. Media Release: 23 Feb 2006. Available from URL: http://www.frx.com Forest Laboratories Inc, Replidyne Inc. Replidyne and Forest Laboratories Announce FDA Acceptance for Review of New Drug Application for Oral Antibiotic Faropenem Medoxomil. Media Release: 23 Feb 2006. Available from URL: http://​www.​frx.​com
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Zurück zum Zitat Voith B, Schuehly U, Voigt U, et al. Influence of food intake on the pharmacokinetics, safety and tolerability of a single dose of faropenem daloxate. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy: 16, 17 Sep 2000 Voith B, Schuehly U, Voigt U, et al. Influence of food intake on the pharmacokinetics, safety and tolerability of a single dose of faropenem daloxate. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy: 16, 17 Sep 2000
15.
Zurück zum Zitat Schmidt A, voith B, Dalhoff A. No evidence of active metabolites of faropenem. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy: 23 (plus poster), 22 Sep 2001 Schmidt A, voith B, Dalhoff A. No evidence of active metabolites of faropenem. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy: 23 (plus poster), 22 Sep 2001
16.
Zurück zum Zitat Voith B, Wilding I, Wray A, et al. Absorption of faropenem daloxate delivered locally to different sites of the gastrointestinal tract by an Enterion capsule. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy: 23 (plus poster), 22 Sep 2001 Voith B, Wilding I, Wray A, et al. Absorption of faropenem daloxate delivered locally to different sites of the gastrointestinal tract by an Enterion capsule. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy: 23 (plus poster), 22 Sep 2001
17.
Zurück zum Zitat Gill SC, Tosiello R. Pharmacokinetics of faropenem following oral administration of faropenem medoxomil in association with thorough QT/QTc evaluation. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 29 (plus poster) abstr. A-1942, 27 Sep 2006 Gill SC, Tosiello R. Pharmacokinetics of faropenem following oral administration of faropenem medoxomil in association with thorough QT/QTc evaluation. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 29 (plus poster) abstr. A-1942, 27 Sep 2006
18.
Zurück zum Zitat Tosiello R, Sprenger C, Echols R, et al. A thorough ECG study of faropenem medoxomil compared to placebo and a positive control. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 24–25 (plus poster) abstr. A1111, 27 Sep 2006 Tosiello R, Sprenger C, Echols R, et al. A thorough ECG study of faropenem medoxomil compared to placebo and a positive control. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 24–25 (plus poster) abstr. A1111, 27 Sep 2006
19.
Zurück zum Zitat Nakashima M, Umemura K. Pharmacokinetics of SUN208 in healthy male volunteers. 35th Interscience Conference on Antimicrobial Agents and Chemotherapy: 136, 17 Sep 1995 Nakashima M, Umemura K. Pharmacokinetics of SUN208 in healthy male volunteers. 35th Interscience Conference on Antimicrobial Agents and Chemotherapy: 136, 17 Sep 1995
20.
Zurück zum Zitat Nagelschmitz J, Koch M, Heizmann WR, et al. Effect of multiple dose treatments with faropenem daloxate in comparison to amoxicillin/clavulanic acid on the normal fecal and oropharyngeal flora of healthy subjects. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy: 22 (plus poster), 22 Sep 2001 Nagelschmitz J, Koch M, Heizmann WR, et al. Effect of multiple dose treatments with faropenem daloxate in comparison to amoxicillin/clavulanic acid on the normal fecal and oropharyngeal flora of healthy subjects. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy: 22 (plus poster), 22 Sep 2001
21.
Zurück zum Zitat Marbury T, Roesch B, Corrado M, et al. A double-blind, randomized, dose ranging study to evaluate the safety of faropenem medoxomil at 300 or 600 mg BID for seven days in healthy volunteers. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy: 396 (plus poster) abstr. L-480, 17 Sep 2007 Marbury T, Roesch B, Corrado M, et al. A double-blind, randomized, dose ranging study to evaluate the safety of faropenem medoxomil at 300 or 600 mg BID for seven days in healthy volunteers. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy: 396 (plus poster) abstr. L-480, 17 Sep 2007
22.
Zurück zum Zitat Kowalsky S, Upchurch J, Rosemore M, et al. Prospective, randomized, double-blind, three-armed, multicenter, comparative trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO, BID for 7 days versus faropenem daloxate 300 mg PO, BID for 10 days versus cefuroxime axetil 250 mg PO, BID for 10 days in the treatment of acute bacterial sinusitis. Study 100288. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 389 (plus poster) abstr. L-575, Dec 2005 Kowalsky S, Upchurch J, Rosemore M, et al. Prospective, randomized, double-blind, three-armed, multicenter, comparative trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO, BID for 7 days versus faropenem daloxate 300 mg PO, BID for 10 days versus cefuroxime axetil 250 mg PO, BID for 10 days in the treatment of acute bacterial sinusitis. Study 100288. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 389 (plus poster) abstr. L-575, Dec 2005
23.
Zurück zum Zitat Echols R, Tlili N, Nikolaidis P, et al. Prospective, randomized, double-blind, multinational, multicenter clinical trial comparing the efficacy and safety of faropenem daloxate 300 mg PO, BID for 7 days with cefuroxime axetil for 7 days (250 mg BID) in the treatment of patients with acute bacterial sinusitis. Study 10186. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 388–389, Dec 2005 Echols R, Tlili N, Nikolaidis P, et al. Prospective, randomized, double-blind, multinational, multicenter clinical trial comparing the efficacy and safety of faropenem daloxate 300 mg PO, BID for 7 days with cefuroxime axetil for 7 days (250 mg BID) in the treatment of patients with acute bacterial sinusitis. Study 10186. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 388–389, Dec 2005
24.
Zurück zum Zitat Siegert R, Berg O, Gehanno P, et al. Faropenem daloxate vs. cefuroxime axetil in the treatment of acute sinusitis. Clinical Microbiology and Infection 8 (Suppl. 1): 327, Apr 2002 Siegert R, Berg O, Gehanno P, et al. Faropenem daloxate vs. cefuroxime axetil in the treatment of acute sinusitis. Clinical Microbiology and Infection 8 (Suppl. 1): 327, Apr 2002
25.
Zurück zum Zitat Dhillon G, Williams H, Corrado M, et al. A phase II double-blind, randomized trial comparing faropenem medoxomil at 300 mg BID for seven days and 600 mg BID for five days in subjects with acute maxillary sinusitis diagnosed by antral tap. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy: 396 (plus poster) abstr. L-481, 17 Sep 2007 Dhillon G, Williams H, Corrado M, et al. A phase II double-blind, randomized trial comparing faropenem medoxomil at 300 mg BID for seven days and 600 mg BID for five days in subjects with acute maxillary sinusitis diagnosed by antral tap. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy: 396 (plus poster) abstr. L-481, 17 Sep 2007
26.
Zurück zum Zitat Echols R, Schürmann D. A multicenter, multinational, prospective, randomized, double-blind study to compare the efficacy and safety of faropenem daloxate 300 mg PO BID for 10 days with co-amoxiclav 500/125 mg PO TID for 10 days in the treatment of adult patients with community-acquired pneumonia. Study 10189. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 393–394 (plus oral presentation) abstr. L708, Dec 2005 Echols R, Schürmann D. A multicenter, multinational, prospective, randomized, double-blind study to compare the efficacy and safety of faropenem daloxate 300 mg PO BID for 10 days with co-amoxiclav 500/125 mg PO TID for 10 days in the treatment of adult patients with community-acquired pneumonia. Study 10189. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 393–394 (plus oral presentation) abstr. L708, Dec 2005
27.
Zurück zum Zitat Drehobl M, Patel T, Echols R. Prospective, randomized, double-blind study comparing faropenem daloxate 300 mg PO BID for 10 days with cefpodoxime 200 mg PO BID for 14 days in the treatment of patients with community-acquired pneumonia. Study 100290. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 388 (plus poster) abstr. L-571, Dec 2005 Drehobl M, Patel T, Echols R. Prospective, randomized, double-blind study comparing faropenem daloxate 300 mg PO BID for 10 days with cefpodoxime 200 mg PO BID for 14 days in the treatment of patients with community-acquired pneumonia. Study 100290. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 388 (plus poster) abstr. L-571, Dec 2005
28.
Zurück zum Zitat Walker G, Upchurch J, Fogarty C, et al. Prospective, randomized, double-blind study comparing faropenem daloxate 300 mg PO BID for 5 days with azithromycin for 5 days (500 mg PO OD on day 1, then 250 mg PO OD on day 2 through 5) in the treatment of patients with acute exacerbation of chronic bronchitis. Study 100291. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 389 (plus poster) abstr. L-576, Dec 2005 Walker G, Upchurch J, Fogarty C, et al. Prospective, randomized, double-blind study comparing faropenem daloxate 300 mg PO BID for 5 days with azithromycin for 5 days (500 mg PO OD on day 1, then 250 mg PO OD on day 2 through 5) in the treatment of patients with acute exacerbation of chronic bronchitis. Study 100291. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 389 (plus poster) abstr. L-576, Dec 2005
29.
Zurück zum Zitat Corrado M, Echols R. A multinational, multi-centre, prospective, double-blind, parallel group, randomized study of faropenem daloxate (BAY 56-6854) oral tablets compared to clarithromycin oral tablets, in the treatment of acute exacerbation of chronic bronchitis. Study 10187. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 388 (plus poster) abstr. L-572, Dec 2005 Corrado M, Echols R. A multinational, multi-centre, prospective, double-blind, parallel group, randomized study of faropenem daloxate (BAY 56-6854) oral tablets compared to clarithromycin oral tablets, in the treatment of acute exacerbation of chronic bronchitis. Study 10187. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 388 (plus poster) abstr. L-572, Dec 2005
30.
Zurück zum Zitat Richard G, Mazzone F, Drehobl M, et al. Prospective, randomized, double-blind study comparing faropenem daloxate 300 mg PO BID for 5 days with trimethoprim/sulfamethoxazole 160/800 mg PO bid for 5 days in treatment of patients with acute, uncomplicated lower urinary tract infections. Study 100286. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 411, Dec 2005 Richard G, Mazzone F, Drehobl M, et al. Prospective, randomized, double-blind study comparing faropenem daloxate 300 mg PO BID for 5 days with trimethoprim/sulfamethoxazole 160/800 mg PO bid for 5 days in treatment of patients with acute, uncomplicated lower urinary tract infections. Study 100286. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 411, Dec 2005
31.
Zurück zum Zitat Davis A, Heaton K, Huck W, et al. Prospective, randomized, double-blind, multi-center trial to compare the efficacy and safety of faropenem daloxate 300 mg PO BID for 5 days versus penicillin VK 500 mg PO TID for 10 days in the treatment of adults and adolescents with acute Streptococcus pyogenes tonsillitis/pharyngitis. Study 100293. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 392, Dec 2005 Davis A, Heaton K, Huck W, et al. Prospective, randomized, double-blind, multi-center trial to compare the efficacy and safety of faropenem daloxate 300 mg PO BID for 5 days versus penicillin VK 500 mg PO TID for 10 days in the treatment of adults and adolescents with acute Streptococcus pyogenes tonsillitis/pharyngitis. Study 100293. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 392, Dec 2005
32.
Zurück zum Zitat Corrado M, Shemer A, Echols R. Prospective, randomized, double-blind, double-dummy, multi-centre comparative trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO BID for 7 days vs co-amoxiclav 625 mg PO TID for 7 days in the treatment of uncomplicated skin and skin structure infections. Study 10190. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 402 (plus poster) abstr. L-1572, Dec 2005 Corrado M, Shemer A, Echols R. Prospective, randomized, double-blind, double-dummy, multi-centre comparative trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO BID for 7 days vs co-amoxiclav 625 mg PO TID for 7 days in the treatment of uncomplicated skin and skin structure infections. Study 10190. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 402 (plus poster) abstr. L-1572, Dec 2005
33.
Zurück zum Zitat Huck W, Heaton K, Elliott S, et al. Prospective, randomized, double-blind, multicenter, comparative trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO BID for 7 days versus cephalexin 500 mg PO BID for 7 days in the treatment of uncomplicated skin and skin structure infections. Study 100292. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 402 (plus poster) abstr. L-1571, Dec 2005 Huck W, Heaton K, Elliott S, et al. Prospective, randomized, double-blind, multicenter, comparative trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO BID for 7 days versus cephalexin 500 mg PO BID for 7 days in the treatment of uncomplicated skin and skin structure infections. Study 100292. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 402 (plus poster) abstr. L-1571, Dec 2005
34.
Zurück zum Zitat Schuehly U, Voith B, Voigt U, et al. Investigation of a potential pharmacokinetic interaction between furosemide and faropenem daloxate after concomitant single-dose administration. Clinical Microbiology and Infection 7 (Suppl. 1): 274–275, 2001 Schuehly U, Voith B, Voigt U, et al. Investigation of a potential pharmacokinetic interaction between furosemide and faropenem daloxate after concomitant single-dose administration. Clinical Microbiology and Infection 7 (Suppl. 1): 274–275, 2001
35.
Zurück zum Zitat Voith B, Schuehly U, Ruf T, et al. Influence of concomitant administration of probenecid on the safety, tolerability, and pharmacokinetics of a single dose of faropenem daloxate. Clinical Microbiology and Infection 7 (Suppl. 1): 274, 2001 Voith B, Schuehly U, Ruf T, et al. Influence of concomitant administration of probenecid on the safety, tolerability, and pharmacokinetics of a single dose of faropenem daloxate. Clinical Microbiology and Infection 7 (Suppl. 1): 274, 2001
36.
Zurück zum Zitat Voith B, Schuehly U, Ruf T, et al. Influence of a pre- and cotreatment with Maalox (Rm) 70 on safety, tolerability, and pharmacokinetics of a single dose of faropenem daloxate. Clinical Microbiology and Infection 7 (Suppl. 1): 274, 2001 Voith B, Schuehly U, Ruf T, et al. Influence of a pre- and cotreatment with Maalox (Rm) 70 on safety, tolerability, and pharmacokinetics of a single dose of faropenem daloxate. Clinical Microbiology and Infection 7 (Suppl. 1): 274, 2001
37.
Zurück zum Zitat Heine H, Rubino CM, Basett J, et al. Pharmacokinetic-pharmacodynamic assessment of faropenem in a lethal murine-Bacil-lus anthracis inhalation post-exposure prophylaxis model. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy: 34 (plus poster) abstr. A-1435, 17 Sep 2007 Heine H, Rubino CM, Basett J, et al. Pharmacokinetic-pharmacodynamic assessment of faropenem in a lethal murine-Bacil-lus anthracis inhalation post-exposure prophylaxis model. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy: 34 (plus poster) abstr. A-1435, 17 Sep 2007
38.
Zurück zum Zitat Heine HS, Miller L, Bassett J, et al. Activity of faropenem against Bla1 and Bla2 beta-lactamase producing strains of Bacillus anthracis. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 178 (plus poster) abstr. E-226, 27 Sep 2006 Heine HS, Miller L, Bassett J, et al. Activity of faropenem against Bla1 and Bla2 beta-lactamase producing strains of Bacillus anthracis. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 178 (plus poster) abstr. E-226, 27 Sep 2006
39.
Zurück zum Zitat Young C, Critchley IA, Janjic N. Activity of faropenem against multi-drug resistant Streptococcus pneumoniae identified in phase III respiratory clinical trials and correlation with clinical microbiological success. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 178 (plus poster) abstr. E-224, 27 Sep 2006 Young C, Critchley IA, Janjic N. Activity of faropenem against multi-drug resistant Streptococcus pneumoniae identified in phase III respiratory clinical trials and correlation with clinical microbiological success. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 178 (plus poster) abstr. E-224, 27 Sep 2006
40.
Zurück zum Zitat Clawson Stone K, Dagan R, Arguedas A, et al. Activity of faropenem against middle ear fluid pathogens from children with acute otitis media in Costa Rica and Israel. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 178 (plus poster) abstr. E-225, 27 Sep 2006 Clawson Stone K, Dagan R, Arguedas A, et al. Activity of faropenem against middle ear fluid pathogens from children with acute otitis media in Costa Rica and Israel. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy: 178 (plus poster) abstr. E-225, 27 Sep 2006
41.
Zurück zum Zitat Singh S, Echols R. Prospective, multi-center, nonblind, uncontrolled trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO, BID for 7 days in the treatment of acute bacterial sinusitis. Study 100287. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 389 (plus poster) abstr. L-574, Dec 2005 Singh S, Echols R. Prospective, multi-center, nonblind, uncontrolled trial to evaluate the efficacy and safety of faropenem daloxate 300 mg PO, BID for 7 days in the treatment of acute bacterial sinusitis. Study 100287. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy: 389 (plus poster) abstr. L-574, Dec 2005
Metadaten
Titel
Faropenem Medoxomil
A0026, BAY 56-6854, BAY 566854, Faropenem Daloxate, SUN 208, SUN A0026
Publikationsdatum
01.03.2008
Verlag
Springer International Publishing
Erschienen in
Drugs in R&D / Ausgabe 2/2008
Print ISSN: 1174-5886
Elektronische ISSN: 1179-6901
DOI
https://doi.org/10.2165/00126839-200809020-00005

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