Dificid again

Last time .... July 2011

Comment: When the Vanco doesn't knock it out ... bring in the big guns. I start tomorrow. Twice a day for 10 days! Praying that this does it! Fidaxomicin (AKA Dificid) ... by Optimer (Stock = OPTR)

Round 5 - Dificid

7 days after my 9 weeks of Vanco (last taken on 7/16), my C-Diff returned on Saturday 7/23. I called the infectious diseases on call Doctor at Methodist Hospital and again was prescribed Vanco. On Tuesday my primary Doctor called and ordered up a 10 day supply of Dificid, a new drug for Clostridium difficile. Kathee picked it up at the hospital last night and I started on it this morning. More on below

FDA approves treatment for Clostridium difficile infection

Excerpts:

The safety and efficacy of Dificid were demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.

“In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C. difficile infection,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea.”

....


Dificid was developed by San Diego-based Optimer Pharmaceuticals Inc.

The following represents how I am feeling:

DIFICID approved by FDA

FDA approves new antibiotic for common hospital-acquired infection

Excerpts

The Food and Drug Administration has approved a new antibiotic to treat an intestinal infection that afflicts more than 700,000 U.S. patients each year and can sometimes prove fatal.

Optimer Pharmaceuticals Inc.'s Dificid tablets were approved Friday to treat Clostridium difficile, an infection that usually affects older patients and can cause symptoms ranging from diarrhea to potentially life-threatening inflammation of the colon. It is most common in hospitals and nursing homes where the bacteria's spores can be found in bed linens, bathrooms and medical equipment.

Clostridium difficile recently surpassed a type of staphylococcus bug as the most common hospital-acquired infection, according to researchers at Duke University Medical Center.

Optimer's twice-a-day tablet is the first new drug approved for the infection in nearly 25 years, according to the company.

In recent decades, some varieties of germs have grown immune to popular antibiotics like penicillin, creating concern about the dwindling number of new antibiotics available. The new drug, known generically as fidaxomicin, is only the third antibiotic cleared by the FDA since 2006, according to Optimer.

"When we started out, this was a relatively small segment of the market and it was not clear how a drug could be better than vancomycin," said Optimer Chief Executive Pedro Lichtinger, referring to the currently prescribed antibiotic. "But our scientists were able to see the growth of this market and the weakness of the current treatment."

In company trials, Dificid worked as well as vancomycin at treating the infection. The drug proved superior at preventing re-infection three weeks after treatment when compared with the older drug.

Comment: I am on week # 4 of my latest round of Vanco. I feel very close to completely healed

Fidaxomicin - a promising new drug for Clostridium difficile

I am half way through my 4 week regimen of Vancomycin. I was in to see Nila Suntharam today and this is the latest:

• I have two weeks left of the Vanco (4 x a day). To continue with this
  
• To commence taking a prescription probiotic. Not sure what this is called as I haven't picked it up yet
  
• To call Dr Suntharam in two weeks to evaluate whether the Vanco should be extended.
  
• She said there is a promising new drug for C-Diff on the horizon. More information here:
  
  • Optimer Pharmaceuticals Submits Rolling New Drug Application to FDA for Fidaxomicin (September 2010)
    
  • New C. diff Drug OK'd by FDA Panel (April 2011)
    
  • DIFICID™ (fidaxomicin) (Optimer site). More on the drug below (quoted from this page)
    

Excerpt:

Fidaxomicin, our lead product candidate, is a new antibiotic with a novel mechanism of action being developed for the treatment of Clostridium difficile infection or CDI, the most common nosocomial, or hospital acquired, diarrhea. We believe that Fidaxomicin offers advantages over current treatments due to its demonstrated activity against C. difficile, low rates of recurrence, evidence of low C. difficile resistance, minimal systemic exposure, limited disruption of normally occurring gastrointestinal bacteria and convenient dosing regimen. Our studies indicate that Fidaxomicin acts by inhibiting RNA polymerase, a bacterial enzyme, which results in the death of specific bacteria such as C. difficile. We currently hold rights to fidaxomicin in all regions of the world except for Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States, or CIS.

Comment: DIFICID™ (fidaxomicin) is still not available but sounds promising. Meanwhile I will be on Vanco until I am better. Thanks for your prayers!