The FDA has approved Orbactiv to treat people with skin infection. This is the third drug approved this year for similar usage.
Orbactiv is an antibacterial drug that can be used to treat adults with acute bacterial skin and skin structure infections (ABSSSI). The U.S. Food and Drugs Administration has given its approval for the usage of this drug, which is administered intravenously.
"The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a press statement. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs."
Not only is Orbactiv the third drug to be approved for similar treatment this year, it is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. It received this title because it is intended to treat a serious or life-threatening infection.
Researchers tested the effectiveness and safety of the drug in two clinical trials including 1,987 individuals. Participants were randomly assigned to receive Orbactiv or vancomycin. Results showed Orbactiv was as effective as vancomycin for the treatment of ABSSSI.
The side effects of Orbactiv include headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhea.
Not all bacteria cause skin infection. Bacteria such as some Staphylococcus species, Corynebacterium spp., Brevibacterium spp and Acinetobacter live on normal skin and cause no harm. Propionibacteria live in the hair follicles of adult skin and contribute to acne. Some bacteria invade normal skin, broken skin from eczema/dermatitis or wounds (causing wound infection). Bacteria, like viruses, may also sometimes result in rashes.
