New Antibiotic Synercid
UNTIL NOW, the last line of defense against the most
aggressive bacterial infections has been the drug
vancomycin ? but germs are increasingly developing
resistance to it. The elderly and people with weakened
immune systems are most at risk.
The need for a new antibiotic was so great that the
Food and Drug Administration for the past year has allowed
hundreds of patients at risk of death from drug-resistant
germs to be treated with Synercid under a special
emergency program, while the agency decided whether the
drug was safe and effective enough for broad sale.
Today, the FDA approved Synercid to treat
vancomycin-resistant enterococcal infections, a
life-threatening infection that strikes thousands of hospital patients.
One recent study estimated as many as 52 percent of
enterococcal infections are now vancomycin-resistant,
making them difficult if not impossible to treat.
But doctors must do the proper laboratory testing
before prescribing Synercid to make sure patients?
infections are caused by the most deadly type of
enterococcus ? called E. faecium, the FDA stressed.
Synercid works well against E. faecium, but is not very
effective against a related and more common enterococcal
infection that other antibiotics still can cure, the FDA said. The drug was also found to be safe and effective for
the treatment of skin and soft tissue infections of some
?staph? and ?strep? bacteria, the FDA said.
NOT A MIRACLE DRUG
But it is not a miracle drug. Synercid doesn?t work as
well as existing antibiotics for some infections, scientists
have stressed ? and because bacteria evolve rapidly,
Synercid resistance eventually will appear, too.
?The drug should be used judiciously ... because for
many patients, it will be a drug of last resort, and we?d like to protect it for as long as possible,? said FDA antibiotics chief Dr. Sandra Kweder.
Synercid was studied in more than 2,000 patients, and
its overall effectiveness at fighting off infection was 52
percent, the FDA said.
The most frequently reported side effects were muscle
and joint pain, nausea, diarrhea, vomiting and rash.
Synercid, an intravenous antibiotic, will be available for
doctors to prescribe beginning Oct. 1.
Synercid, manufactured by Rhone-Poulenc Rorer, is
the first in a new class of antibiotics called streptogamins to be sold in the United States, and it appears to work by
dealing bacteria a one-two punch.
It is a combination of two drugs ? quinupristin and
dalfopristin ? that inhibit two different methods of bacterial protein synthesis. That combination effect makes the chemicals 16 times more potent together than either
molecule alone, the company says.
OTHER DRUGS IN THE WORKS
Rhone-Poulenc Rorer is just one of many companies in
the antibiotics business. Driven by the rapid rise of bacteria resistant to the more than 150 antibiotics on the market, drug and biotech companies are betting billions on
developing new drugs to fight superbugs.
?The handwriting is on the wall that the situation with
drug-resistant germs is getting worse, not better,? said
Hambrecht & Quist analyst Richard van den Broek.
For that reason, the antibiotic business in now in
?reinvestment mode,? he said.
The payoff for successful new anti-infectious therapies
could be huge. Antibiotics pull in $20 billion a year in
worldwide sales. A niche medication could generate at least
$200 million in annual sales. And a powerful, broad-ranging
drug could easily hit $1 billion, analysts said.
Bert Spilker, senior vice president for scientific and
egulatory affairs with the Pharmaceutical Research and
Manufacturers of America, said about 27 antibiotic
candidates are in development. ?Companies realize this is a very important public
health issue and they realize something new and novel has to
be done,? Spilker said. |
