The trial aims to evaluate the effects of prescribing antibiotics after tooth extraction. 152 dental patients aged 18 to 50 will be randomly assigned. The study will assess infection rates, healing times, pain, and adverse effects in patients who receive antibiotics versus those who do not. The trial will be conducted at the Oral and Maxillofacial Surgery Department, Dental Unit, Chittagong Medical College. Data analysis will involve the use of the χ²-test, t-tests, and logistic regression, with a significance level of 5%. Ethical considerations include obtaining informed consent from all participants, and safety will be monitored by an independent expert team.

Start Date01 Jan 2025

Sponsor / Collaborator

Chittagong Medical College

NCT06709196 / Not yet recruitingPhase 4IIT

REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.

The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis.
Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively.
The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.

Start Date01 Jan 2025

Sponsor / Collaborator

Rigshospitalet

NCT05165212 / WithdrawnPhase 4IIT

Oral Amoxicillin Challenge in the Primary Care Setting

The purpose of this project is to identify clinic patients reporting penicillin allergy who are low risk for allergic reaction, and then invite them to participate in an oral amoxicillin challenge in their primary office without need for referral to allergy/immunology. If the patient is able to tolerate oral amoxicillin, the antibiotic allergy in question will be removed from the patient's chart.

Start Date31 Dec 2024

Sponsor / Collaborator

State University of New York at Buffalo

100 Clinical Results associated with Amoxicillin/Clavulanate Potassium

100 Translational Medicine associated with Amoxicillin/Clavulanate Potassium

100 Patents (Medical) associated with Amoxicillin/Clavulanate Potassium

2,914

Literatures (Medical) associated with Amoxicillin/Clavulanate Potassium

01 Dec 2024·MOLECULAR BIOLOGY REPORTS

Molecular characteristics and antimicrobial resistance profiles of Staphylococcus aureus isolates from burns

Article

Author: Hamad, Entisar Mahdi ; Kadhum, Duaa Adnan ; Fahad, Morooj Ali

BACKGROUND:

Burns are a problem that affects millions of individuals around the world.

OBJECTIVE:

This research aimed to analyze the genetic characteristics and antibiotic resistance of Staphylococcus aureus strains isolated from patients with burns. Identifying the genetic variations of three local strains of Staphylococcus aureus isolated from burns.

MATERIALS AND METHODS:

Swab samples were collected from eighty sources (burns). Using sterile swabs containing media collected from patients treated at Baqubah Teaching Hospital between July 2022 and the end of September 2022, these samples were then cultured on blood agar and brain heart infusion agar. A total of twenty-four hours were spent incubating the cultured samples in an aerobic environment at 37 °C. During this time, isolated growing colonies showed characteristic growth, color, and hemolysis, while suspicious colonies were cultured for further identification.

RESULTS:

Our results indicated the presence of several polymorphisms that were distributed in the investigated samples. However, almost all observed variations were concentrated only in the S2 isolates. The construction of phylogenetic trees confirmed this notion by positioning these S2-based amplicons to distinct categories within Staph. aureus organisms. Furthermore, the phylogenetic tree offered additional tools for the guaranteed identity of the samples that were analyzed. Consequently, the utilization of the PCR-sequencing approach in three DNA samples belonging to these local bacterial isolates has resulted in the confirmation of the identity of this strain. However, particular emphasis should be placed on S2 isolate as it has special variants that differ from its mates, in terms of its metabolic as well as phylogenetic consequences. Therefore, S2 isolates may represent a new strain that requires a whole genome sequencing strategy to validate its identity within Staph. aureus organisms. S.aureus resistance was 100% (Augmentin and Tetracycline), and 90% (Azithromycin and Trimethoprim), while Cefotaxime and Chloramphenicol recorded (75%, and 85%) respectively.

01 Dec 2024·Molecular biology reports

High carriage of plasmid-mediated quinolone resistance (PMQR) genes by ESBL-producing and fluoroquinolone-resistant Escherichia coli recovered from animal waste dumps

Article

Author: Olowomofe, Temitayo Omotunde ; Akinlabi, Olabisi Comfort ; Olaposi, Adedolapo Victoria ; Adekanmbi, Abimbola Olumide ; Joel, Elizabeth Omokoshi

BACKGROUND:

There has been a rise in the consumption of fluoroquinolones in human and veterinary medicine recently. This has contributed to the rising incidence of quinolone resistance in bacteria. This study aimed at the determination of the antibiotic resistance profile of ESBL-producing and fluoroquinolone-resistant E. coli (FQEC) isolated from animal waste obtained from the waste dumps of an agricultural farm and their carriage of genes encoding PMQR.

METHODS AND RESULTS:

Isolation of ESBL-producing E. coli from animal waste samples was done on CHROMagar ESBL, while presumptive isolates were purified, and identified via the detection of uidA gene. Susceptibility to a panel of ten antibiotics was done using the disc diffusion method, and detection of PMQR genes (qnrA, qnrB, qnrS, aac(6')-lb-cr, qepA and oqxAB) was done using monoplex and duplex PCR. Twenty-five ESBL-producing and FQEC were obtained from the cattle (6), piggery (7) and poultry (12) waste dumps of the farm. There was 100% resistance to cefpodoxime, cefotaxime, enrofloxacin, trimethoprim-sulfamethoxazole and penicillin by the isolates. The resistance to the other antibiotics was streptomycin (48%), ceftazidime (24%), while no isolate resisted amoxicillin-clavulanate and imipenem. The frequencies of PMQR genes detected were; qnrA (96%), oqxAB (96%), qnrB (92%), while qnrS was detected in 88% (22) of the isolates. Aminoglycoside acetyltransferase (aac(6')-lb-cr) and quinolone efflux pump (qepA) were each detected in 20 (80%) of the isolates.

CONCLUSIONS:

This study showed that animal wastes disposed indiscriminately into dumps could be a budding 'hotspot' for multidrug resistant, ESBL-producing and fluoroquinolone-resistant E. coli carrying multiple genes encoding resistance to fluoroquinolone antibiotics.

01 Dec 2024·Journal of Global Antimicrobial Resistance

First report of a carbapenem-resistant Aeromonas veronii environmental isolate in the United States co-harboring two carbapenemase genes

Article

Author: Estrada, Rafael ; Ruiz, Cristian

OBJECTIVES:

The spread of carbapenem-resistant bacteria (CRB), and especially carbapenemase-producing CRB, is a global public health threat. Among them, Aeromonas species are of increasing concern because these emerging opportunistic pathogens are widespread in the environment and have increasingly been found to be resistant to carbapenems. The aim of this study was to investigate the genome and carbapenem-resistance determinants of Aeromonas veronii SS-M2-3, a highly carbapenem-resistant, carbapenemase-producing, river isolate from California (U.S.).

METHODS:

We first used disk diffusion assays to characterize the susceptibility profile to carbapenems and other antibiotics of A. veronii SS-M2-3. We next used whole-genome sequencing using the Illumina platform and bioinformatics analysis to characterize the resistome of this isolate and identify its carbapenemase genes.

RESULTS:

A. veronii SS-M2-3 was resistant to all carbapenems tested and amoxicillin-clavulanic acid, whereas it was sensitive to cefotaxime and all non-β-lactam antibiotics tested. Whole genome sequencing of this isolate revealed a complex resistome that included multidrug efflux pump genes and three chromosomal β-lactamase genes. These three genes encoded for highly conserved variants (82% to 97% amino acid identity) of the ChpA3 subclass B2 metallo-carbapenemase, OXA-12 class D carbapenemase and the FOX-2 class C β-lactamase. This is the first report of an environmental A. veronni isolate from the U.S. co-harbouring two carbapenemase genes.

CONCLUSIONS:

These findings reveal that natural aquatic environments in the U.S. represent an underappreciated reservoir of carbapenem-resistant Aeromonas veronii isolates that can carry multiple carbapenemase genes.

News (Medical) associated with Amoxicillin/Clavulanate Potassium

11 Dec 2024

·www.globenewswire.com

Phathom Pharmaceuticals Submits Citizen Petition to FDA Seeking Correction of Orange Book Listings for VOQUEZNA® (vonoprazan) Tablets

Citizen Petition seeks correction of expiration date for New Chemical Entity (NCE) exclusivity on VOQUEZNA (vonoprazan) tablets Orange Book listingsPhathom believes applicable law mandates a 10-year NCE exclusivity period (from date of first approval of drug containing vonoprazan) benefitting all vonoprazan-based products, with exclusivity until May 3, 2032 FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today it has submitted a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA). The petition formally requests correction of the Orange Book listings for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets to accurately reflect the full 10-year NCE exclusivity period until May 3, 2032. The update would align the VOQUEZNA tablets Orange Book listings to reflect the same period of NCE exclusivity that was granted upon approval of vonoprazan-based VOQUEZNA TRIPLE PAK® and VOQUEZNA DUAL PAK® in May 2022. The statutory 10-year exclusivity period encompasses the five-year standard exclusivity period for NCEs as extended by the additional five years by operation of the Generating Antibiotic Incentives Now (GAIN) Act. As VOQUEZNA tablet products contain the same drug substance with the active moiety, vonoprazan, they should be entitled to the same protection. The main points addressed in Phathom’s Citizen Petition include: New Chemical Entity Exclusivity Provisions: The approval of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in May 2022 triggered a 10-year NCE exclusivity period by operation of the GAIN Act, tied to the drug substance containing vonoprazan, which had never previously been approved. This exclusivity period expires in May 2032. Under the law and FDA’s longstanding interpretations of it, NCE exclusivity precludes the submission of any Abbreviated New Drug Application (ANDA) or 505(b)(2) New Drug Application (NDA) referencing any drug containing vonoprazan for the NCE exclusivity period, including VOQUEZNA tablets.The GAIN Act: The NCE exclusivity period awarded upon approval of VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK is 10 years. This is because the GAIN Act’s application to the approval of VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK was to extend, by five years, the underlying NCE exclusivity tied to the drug substance containing vonoprazan. While the GAIN Act includes certain limitations on the application of the extension, none of these exceptions have any effect on the 10-year NCE exclusivity period already awarded and honored by the FDA, and such 10-year NCE exclusivity period equally benefits any vonoprazan-containing products, including VOQUEZNA tablets.Established and Sound Public Policy: As mandated by the plain language of the applicable statutes and the FDA’s longstanding interpretations, Phathom requests that the FDA promptly correct the Orange Book to accurately reflect the statutorily-required 10-year period of NCE exclusivity for vonoprazan in the Orange Book listings for the VOQUEZNA tablet products, identifying the correct expiry date of May 3, 2032. “We are committed to ensuring VOQUEZNA tablets receive the full exclusivity protections in accordance with the FDA's longstanding policies and the clear language of the law,” said Terrie Curran, President and Chief Executive Officer of Phathom Pharmaceuticals. “We remain confident in our position that VOQUEZNA tablets are entitled to the full ten-years of NCE exclusivity on the basis of the approval of vonoprazan in VOQUEZNA TRIPLE PAK and DUAL PAK. If corrected, we expect NCE exclusivity for VOQUEZNA tablets until May 3, 2032, which is an enhancement to our patent term exclusivity that is expected to be extended into 2030.” Phathom expects the CP and related docket information to be made available on the www.regulations.gov website in the coming days. The FDA must provide a response to the petition within 180 days from the date of submission. The response will either approve the petition, deny or dismiss the petition, or provide a tentative response indicating why the agency hasn’t been able to reach a decision. The Company believes that a CP affords the FDA the ability to analyze the request under an established framework, and ultimately formalize its decision in accordance with its procedural regulations. About VOQUEZNA®VOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the U.S. rights to vonoprazan from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America. About Phathom Pharmaceuticals, Inc.Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the treatment of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about: the ultimate decision by the FDA on the action requested in the CP and the timing any FDA action regarding the CP; the possible extension of NCE exclusivity to VOQUEZNA tablets; and the expected duration of patent term extension for VOQUEZNA. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the FDA may reject our request to correct the Orange Book listings identifying the expiration date for the NCE exclusivity period on the VOQUEZNA tablets Orange Book listings; the FDA may take longer that we expect to act on our CP, if at all; members of the public may comment on our CP which may influence the FDA’s decision; our ability to obtain and maintain intellectual property protection, including patent term extensions, and non-patent regulatory exclusivity for vonoprazan; we may face competition earlier than expected if we lose or fail to obtain any of our patent protection or non-patent regulatory exclusivity for VOQUEZNA tablets; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. MEDIA CONTACTNick Benedetto1-877-742-8466media@phathompharma.com INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@phathompharma.com © 2024 Phathom Pharmaceuticals. All rights reserved.VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.

Drug ApprovalLicense out/inNDA

28 Oct 2024

·pipelinereview.com

Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades –Company to Host Conference Call on Monday, October 28 th at 8:30 a.m. EDT– DUBLIN, Ireland and CHICAGO, IL, USA I October 25, 2024 I Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for ORLYNVAH™ and the first FDA-approved product for Iterum. “We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of ORLYNVAH™. ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” said Corey Fishman, Iterum’s Chief Executive Officer. “As the first oral penem approved in the U.S., ORLYNVAH™ offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH™ with the goal of maximizing value for our stakeholders.” The FDA approval of ORLYNVAH™ was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of ORLYNVAH™ compared to ciprofloxacin (SURE 1) and Augmentin™ (REASSURE) in the treatment of adult women with uUTI. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin™ in the Augmentin™ susceptible population. ORLYNVAH™ was generally well tolerated in both SURE 1 and REASSURE clinical trials. “The FDA approval of ORLYNVAH™ is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community.” Conference Call Iterum will host a conference call on Monday, October 28, 2024, at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows: United States: 1 833 470 1428 / International: 1 404 975 4839 Access code: 936149 The conference call replay will be available in the Events & Presentations section of Iterum’s website following the call. About uUTIs UTIs are among the most common bacterial infections encountered in the community. uUTIs are infections of the bladder occurring mainly in women. Up to 60% of women will have a uUTI in their lifetime. Up to 40% of women with a history of uUTI will have a recurrence of their infection. There are approximately 40 million uUTI prescriptions generated annually in the United States, and we estimate approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. Rising antibiotic resistance, an aging population with comorbidities and sub-optimal safety profiles of existing oral treatment options are making antibiotic selection more challenging for treating physicians. About ORLYNVAH™ ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTI. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins. INDICATION AND IMPORTANT SAFETY INFORMATION INDICATIONS & USAGE ORLYNVAH™ a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uUTI caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Limitations of Use ORLYNVAH™ is not indicated for the treatment of: Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORLYNVAH™ and other antibacterial drugs, ORLYNVAH™ should be used only to treat uUTI that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ADVERSE REACTIONS The most common adverse reactions (≥2%) in patients treated with ORLYNVAH™ were diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting. DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS To report SUSPECTED ADVERSE REACTIONS, contact Iterum Therapeutics plc at 1-866-414-SULO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Iterum Therapeutics plc Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its NDA for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com . SOURCE: Iterum Therapeutics

Phase 3Drug ApprovalFast TrackQualified Infectious Disease Product

28 Oct 2024

·www.biospace.com

Iterum Wins FDA Approval For Oral UTI Antibiotic, Seeks ‘Strategic Transaction’ for Asset

iStock, hapabapa Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders. The FDA on Friday signed off on Iterum Therapeutics’ oral antibiotic sulopenem etzadroxil and probenecid, which will now be marketed as Orlynvah, for the treatment of uncomplicated urinary tract infections in adult women. Orlynvah, Iterum’s first FDA-approved product, is cleared for three designated microorganisms— Escherichia coli , Klebsiella pneumoniae and Proteus mirabilis —and is indicated for women with limited or no available alternative oral antibiotic options. Iterum CEO Corey Fishman in a statement called Orlynvah’s approval a “historic milestone” that “offers new hope for patients suffering from difficult-to-treat uUTIs (uncomplicated urinary tract infections).” Orlynvah is “the first oral penem approved in the U.S.,” Fishman said, noting it is “an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians.” To bring Orlynvah to the market and boost its commercialization efforts, Iterum will “renew” its “efforts to achieve a strategic transaction involving Orlynvah with the goal of maximizing value for our stakeholders,” Fishman said. The FDA’s decision on Friday was backed by Iterum’s clinical data for Orlynvah, including two Phase III trials. In the pivotal late-stage REASSURE study, topline data which were released in January 2024 , the oral sulopenem showed statistical non-inferiority to Augmentin (amoxicillin/clavulanate) in terms of overall response. Orlynvah significantly outperformed Augmentin at overall treatment success. Safety outcomes were comparable between treatment groups. Iterum’s data package also included findings from the pivotal Phase III SURE 1 study, which in June 2020 showed that the oral sulopenem was better than ciprofloxacin in patients with quinolone-resistant infections. SURE 1 also found Orlynvah to be safe, with adverse events developing at a comparable frequency as in the ciprofloxacin-treated group. Iterum filed a New Drug Application to the FDA but failed to secure approval. In July 2021, the regulator handed the Dublin, Ireland-based biotech a Complete Response Letter, noting that while SURE 1 had established that oral sulopenem was superior than ciprofloxacin, Iterum would need to run an additional trial that uses a different comparator drug. Iterum filed its resubmission earlier this year, after which the FDA convened its Antimicrobial Drugs Advisory Committee. The panel was not asked to vote on the approvability of Orlynvah, but Fishman said in a statement after the meeting that the company was “encouraged” by the discussion, “which acknowledged oral sulopenem as an important treatment option for certain patients with uUTI.”

Phase 3Drug ApprovalClinical ResultQualified Infectious Disease Product

100 Deals associated with Amoxicillin/Clavulanate Potassium

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KEGG	Wiki	ATC	Drug Bank
-	-	J01CR02	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bone and joint infections	CA	Sandoz Canada, Inc.	28 Jan 2020
Genital Diseases, Female	CA	Sandoz Canada, Inc.	28 Jan 2020
Intraabdominal Infections	CA	Sandoz Canada, Inc.	28 Jan 2020
Severe infection	CA	Sandoz Canada, Inc.	28 Jan 2020
Skin structures and soft tissue infections	CA	Sandoz Canada, Inc.	28 Jan 2020
Acute bacterial sinusitis	US	USAntibiotics	25 Sep 2002
Bronchitis, Chronic	AU	Aspen Pharmacare Australia Pty Ltd.	08 Jan 1998
Community Acquired Pneumonia	AU	Aspen Pharmacare Australia Pty Ltd.	08 Jan 1998
Acute Bronchitis	JP	GlaxoSmithKline KK	01 Aug 1988
Pharyngitis	JP	GlaxoSmithKline KK	01 Aug 1988
Tonsillitis	JP	GlaxoSmithKline KK	01 Aug 1988
Cystitis	JP	GlaxoSmithKline KK	29 Jul 1985
Gonorrhea	JP	GlaxoSmithKline KK	29 Jul 1985
Intrauterine infection	JP	GlaxoSmithKline KK	29 Jul 1985
Lymphadenitis	JP	GlaxoSmithKline KK	29 Jul 1985
Non-complicated skin and skin structure infection	JP	GlaxoSmithKline KK	29 Jul 1985
Pyelonephritis	JP	GlaxoSmithKline KK	29 Jul 1985
Pyoderma	JP	GlaxoSmithKline KK	29 Jul 1985
respiratory tract; infection, chronic	JP	GlaxoSmithKline KK	29 Jul 1985
Bacterial Infections	US	USAntibiotics	22 Jul 1985

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute sinusitis	Phase 3	JP	GSK Plc	30 Aug 2013
Cataract Anterior Polar Dominant	Phase 2	-	GSK Plc	23 Jun 2023
Acute pyelonephritis	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	10 Feb 2023
Buruli Ulcer	Phase 2	BJ	GSK Plc	01 Dec 2021
Suppuration	Phase 2	CN	Shandong Teruilin Medicine Technology Development Co., Ltd.	19 May 2015
Genitourinary tract infection	Phase 2	CN	Suzhou Erye Pharmaceutical Co., Ltd.	15 May 2013
Suppurative tonsillitis	Phase 2	CN	Suzhou Erye Pharmaceutical Co., Ltd.	15 May 2013
Acute otitis media	Phase 1	CN	Zhongshan Lienpu Pharmaceutical Co., Ltd	22 Apr 2024
Cellulitis	Phase 1	CN	Zhongshan Lienpu Pharmaceutical Co., Ltd	22 Apr 2024
Osteomyelitis	Phase 1	CN	Zhongshan Lienpu Pharmaceutical Co., Ltd	22 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05753735 (CTgov)	Phase 2	Pancreatic Fistula	3	Piperacillin/Tazobactam (Standard Perioperative Antibiotics)	vbovimsuub(jptfnhonrg) = pmexjfzzfx usfavevyzq (ltwjwkuuwt, alunbbayyf - maoepzwihd) View more	-	24 Sep 2024
				Piperacillin/Tazobactam+Amoxicillin/ Clavulanic acid (Extended Antibiotic Prophylaxis)	wibkifzlyc(guzcfsvmyx) = matmvyijdp rrgpxrumff (iwsjakxvlq, flxadngzqf - hykitenkua) View more
NCT04600752 (CTgov)	Phase 4	Acute otitis media \| Respiratory Tract Infections	310	Augmentin (ES)-600 (Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600)	msjtwzocbh(piftdybfoh) = gajunjauuf kxjaklfunv (nkcgficsjr, sukhygylvw - gwdffswtlx) View more	-	25 Apr 2024
				Augmentin (ES)-600 (Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600)	msjtwzocbh(piftdybfoh) = mexowbsvwd kxjaklfunv (nkcgficsjr, oupygvbupk - icwrtdpzst) View more
NCT03174184 (COMRADE, CTgov)	Phase 2	Pulmonary Tuberculosis	112	MEROPENEM 2 grams TID+Rifampin+Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tablet (Rifampin Resistant A)	dmszyjarbg(gqcvwkeuan) = pdrssabrts hnvycbcuac (lpvmjfjbju, hbrffwqaha - pjfdpnebwx) View more	-	19 Jul 2023
				MEROPENEM 2 grams TID+Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tablet (Rifampin Resistant B)	dmszyjarbg(gqcvwkeuan) = sxxwvhjwtt hnvycbcuac (lpvmjfjbju, dcsnmoigjy - cdojtudsbj) View more
NCT02554383 (CTgov)	Phase 3	Acute sinusitis	515	Amoxicillin-clavulanate (Amoxicillin-clavulanate)	xpjccjrvma(ywjevpcbzx) = vztdncmlif mkrpugjrra (ofrbkrtgfj, jeuqdhygnc - lxpdwgnagz) View more	-	08 Jun 2023
				Placebo (Placebo)	xpjccjrvma(ywjevpcbzx) = plceayjgqi mkrpugjrra (ofrbkrtgfj, hvqmvqivhs - dttxdsglqb) View more
NCT02517099 (PrIGMa, CTgov)	Phase 2	Asthma \| Inflammation \| Infectious Diseases	60	Beclometasone+Azithromycin+Co-amoxiclav (Pathological Phenotype)	wuhulsextz(ucomqmzqmo) = dwjpgqasnm jmbokrjwsn (clnaetiofx, nejkgstpza - njwdjnrsiw) View more	-	06 Mar 2023
				Beclometasone+Azithromycin+Co-amoxiclav (Clinical Guidelines)	wuhulsextz(ucomqmzqmo) = ferdqeatgw jmbokrjwsn (clnaetiofx, lzqbqqgxxj - gouxuqukxg) View more
NCT02724410 (CTgov)	Not Applicable	Appendicitis	82	peripheral inserted central Catheter+home intravenous ertapenem (Home Intravenous Ertapenem and PICC)	fdhmpkfqnf(wqsveepuzj) = buekkcplmu rllooaentf (bplvnoxfuw, omrqkvqvjr - lrnqmwkllr) View more	-	23 Mar 2022
				home oral amoxicillin-clavulanate (Home Oral Amoxicillin-clavulanate)	fdhmpkfqnf(wqsveepuzj) = luwbigfgxd rllooaentf (bplvnoxfuw, bonwmlewns - tzfjdaadvq) View more
Antibiocor (EASL2021)	Phase 3	Hepatitis, Alcoholic	284	Prednisolone plus antibiotics	fydtfwevey(dgivdgdcgl) = mfpwiarfcd xdswwwfajo (bpfhoxyjhg ) View more	Negative	23 Jun 2021
				Prednisolone plus placebo	fydtfwevey(dgivdgdcgl) = yvxpydqyjn xdswwwfajo (bpfhoxyjhg ) View more
NCT02891915 (CTgov)	Phase 4	Community Acquired Pneumonia \| Cataract Anterior Polar Dominant	385	aminopenicillin+clavulanate+amoxicillin trihydrate+Cefdinir (Short Course)	hywxdornby(ywjqhgspcw): Pr (Higher DOOR in Short-Course) = 0.69 (95% CI, 0.63 - 0.75), P-Value = <0.001 View more	-	03 Feb 2021
				aminopenicillin+clavulanate+amoxicillin trihydrate+Amoxicillin-Clavulanate+Cefdinir (Standard Course)
NCT02927834 (CTgov)	Not Applicable	Chronic sinusitis	24	Augmentin (Antibiotic Only)	fkjaoqvnqa(tyelbekfxg) = toisccwcdb ahebkdsigc (jpawcohzfx, doajozgoqm - wjxywfyclo) View more	-	29 Dec 2020
				6 day Prednisone+Augmentin (Augmentin With 6 Day Steroid)	fkjaoqvnqa(tyelbekfxg) = kfwrxkpgsz ahebkdsigc (jpawcohzfx, lerrwyoefq - qyyyxjcaxq) View more
ERS2020	Not Applicable	Protracted bronchitis caused by bacterium	106	4-wks of amoxicillin-clavulanate	mgblbkmrek(trcycwxngv) = dfavwjaivm qdqfqaaajw (urhgmdqaie ) View more	Negative	07 Sep 2020
				2-wks of amoxicillin-clavulanate followed by 2-wks placebo	mgblbkmrek(trcycwxngv) = yejgzknhvd qdqfqaaajw (urhgmdqaie ) View more

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