Cubist Sivextro approved by FDA to treat skin infections


Sivextro, an antibacterial drug created to treat skin infections, was approved for use on Friday, June 20.

In the face of serious infections such as MRSA and strains of Streptococcus, this drug, also known as tedizolid phosphate, and others of its kind are an urgent necessity. Many previous drugs are increasingly becoming useless due to antimicrobial resistance.

The U.S. Food and Drug Administration echoed this sentiment, approving Sivextro for use through an expedited review process. The drug, made by Massachusetts-based pharmaceutical company Cubist, was approved as a treatment for ABSSSI, or acute bacterial skin and skin structure infections. It is the second drug in the past month to gain FDA-approval for patients with these infections. Dalvance was approved on May 23.

Edward Cox, director of the FDA's Office of Antimicrobial Products, says the drug is "a new treatment option for serious skin infections," in a statement released by the agency.

The drug received the FDA designation of "qualified infectious disease product" (QIDP), and was approved through a faster reviewing system set forth by the GAIN Act, (Generating Antibiotic Incentives Now) that was passed by Congress in 2012. The GAIN Act, in addition to the QIDP designation, gives Sivextro not only a faster approval but also five years added selling time without competition from other generic brands.  Five years of no competition is a definite leg up for Cubist's Trius Therapeutics, a $707 million acquisition for the company, and the developer of the Cubist drug.

Clinical trials with 1,315 adults were used to measure the safety and efficacy of Sivextro in comparison to a drug used for similar purposes. Sivextro was compared to linezolid, an antibacterial drug used for treating ABSSSI, and was shown to be just as effective. Patients in the clinical trials reported nausea, headaches, diarrhea, vomiting and dizziness as side effects of Sivextro. While the improvements in skin infections outweighed the side effects significantly, patients with decreased white blood cell count should use other therapies as the Sivextro trials were not evaluated for them.

Patients with ABSSSI have skin lesions that can be caused by burns and wounds that spread and can become infected with pus, leading to intense pain. New, anti-resistance drugs for these infections are being pushed to the forefront of drug discovery processes.

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