Wired News – Melinta Launched Intravenous and Oral Formulations of Baxdela(TM) in the US
LONDON, UK / ACCESSWIRE / January 31, 2018 / Active-Investors.com has just released a free research report on Melinta Therapeutics, Inc. (NASDAQ: MLNT). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=MLNT as the Company’s latest news hit the wire. On January 29, 2018, the Company announced that it has launched intravenous and oral formulations of Baxdela™ (delafloxacin) in the United States for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. Baxdela™ does not require dosage adjustments due to weight, hepatic impairment, or mild-moderate renal impairment, there are no food effects, and there is minimal potential for drug interactions. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Melinta Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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Melinta Will Market Baxdela™ Leveraging an Industry-Leading Commercial Sales Team
The Company plans to market Baxdela™ nationwide leveraging an industry-leading commercial sales team. Baxdela™ joins a strong portfolio of infectious disease products that will be marketed by Melinta, including Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for injection.
Launch is Enhanced by Availability of Three Antimicrobial Susceptibility Tests
Mike McGuire, Senior Vice President of Melinta Commercial, stated that Baxdela™ will be an important treatment option for providers treating serious skin infections in both the hospital and community settings. These patients often present treatment challenges owing to their underlying medical conditions, which makes optimal antibiotic selection difficult. Mike added that the launch has the support of an experienced sales team and is further enhanced by the availability of three antimicrobial susceptibility tests that offer providers a full set of clinical tools to determine how to treat patients appropriately.
FDA Cleared ASTs Concurrent with Baxdela™ Launch in the US
In October 2017, the US Food and Drug Administration (FDA) cleared three antimicrobial susceptibility tests (ASTs) that would be available to guide physicians towards the appropriate usage of Baxdela™. The three ASTs that were cleared are: Hardy Diagnostics’ Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk™), Liofilchem® Delafloxacin MIC Test Strip (MTS), and Thermo Scientific™ Sensititre™ MIC System. ASTs are used to determine how well specific antibiotics work against bacterial pathogens and they are vital for physicians to understand the appropriate use of an antibiotic.
FDA approved Baxdela™ for the treatment of ABSSSI in adults caused by susceptible bacteria, on June 19, 2017. The Baxdela™ New Drug Application (NDA) approvals were supported by two Phase-3 studies in patients with ABSSSI, demonstrating in-vitro and clinical activity against Gram-positive and Gram-negative pathogens, including activity against MRSA (methicillin-resistant Staphylococcus aureus).
What is Acute Bacterial Skin and Skin Structure Infections?
A skin and skin structure infection (SSSI), also referred to as acute bacterial skin and skin structure infection (ABSSSI), is an infection of skin and associated soft tissues (such as loose connective tissue and mucous membranes). The pathogen involved is usually a bacterial species. Such infections often require treatment by antibiotics. ABSSSI includes infections with resistance to previously effective antimicrobials.
About Baxdela™
Baxdela™ (Delafloxacin)is an anionic fluoroquinolone antibiotic, a class currently used in one out of three hospital-treated infections. It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. Baxdela™ provides for convenient administration with both intravenous and oral forms. The most common adverse reactions in patients treated with Baxdela were nausea, diarrhea, headache, transaminase elevations and vomiting. A FDA-approved patient labeling guide is available for patients taking Baxdela™.
About Melinta Therapeutics, Inc.
Founded in 2000, Melinta Therapeutics is a commercial-stage biopharmaceutical company dedicated to saving lives threatened by the global public health crisis of bacterial infections, through the development and commercialization of novel antibiotics that provide new and better therapeutic solutions. The Company is headquartered in New Haven, Connecticut.
Stock Performance Snapshot
January 30, 2018 – At Tuesday’s closing bell, Melinta Therapeutics’ stock dropped 3.01%, ending the trading session at $14.50.
Volume traded for the day: 76.71 thousand shares.
Stock performance in the previous three-month period – up 36.47%
After yesterday’s close, Melinta Therapeutics’ market cap was at $468.35 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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