Antibiotics become ineffective when bacteria either develop a resistance to them or patients fail to finish a course. Thankfully, a new drug recently approved by the Food and Drug Administration (FDA) can solve both these problems. Orbactiv will be used to treat acute bacterial skin and skin structure infections (ABSSSI). The innovative medication can provide help to patients who have a resistance to older antibiotics and delivers a complete course of treatment in only one dose.
Orbactiv is the creation of Medicines Co., and is classified as a generic vancomycin, the go-to treatment option for the drug-resistant MSRA, Reuters reported. It is only one of three FDA-approved skin infection medicines developed by Medicine Co., in the past year, something which Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, described as demonstrating “that we are making progress in increasing the availability of treatment options for patients and physicians," Science World Report reported. What makes Obactiv so extraordinary is its ability to comprise a complete full course of therapy in one 1200-milligram dose. This is something no other drugs in the market are capable of doing. Other antibiotics like vancomycin require intravenous infusions over the course of seven to 10 days.
Orbactiv did well in its clinical trials. Researchers administered the drug to 1,959 patient and results were found to be more effective than treatment with vancomycin. Side effects ranged from diarrhea, vomiting, headache, and nausea. Following the trials, the FDA marked Orvactiv as a "qualified infectious disease product," News Channel Daily reported. However, it was noted that when used in combination with the popular blood thinner, warfarin, Orbactiv could speed up the risk of bleeding.
The drug is not short of fans either. Clive Meanwell, chairman and CEO of The Medicines Co., explained his belief that the recent FDA approval shows an important advancement in the treatment of skin infections. It is expected that U.S. sales of Orbactiv could reach $150 million by 2021. Still, the FDA believes that Orbactiv’s approval does not signal the end of drug developments. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs," Cox said.
The FDA describes an ABSSSI as a bacterial infection of the skin with a lesion size area of at least 75 cm2. They are commonly caused by the bacteria Streptococcus pyogenes and Staphylococcus aureus, but less common cases may be prompted by different pathogens. Each year, ABSSSI leads to the hospitalization of about 5.2 million patients in the United States and Western Europe alone, Reuters reported.