These drugs recently were approved by the FDA:
• Tipranavir (Aptivus) by Boehringer Ingelheim Pharmaceuticals. The FDA has approved tipranavir (Aptivus) capsules, an HIV protease inhibitor, to be given with ritonavir for treatment of HIV-1-infected adults. This is the second drug approved for patients with advanced HIV disease.
Tipranavir, when used together with ritonavir, was shown to be an effective treatment for patients who had already used many HIV medicines and had a type of virus resistant to currently available anti-HIV medicines. Taking 200 mg ritonavir twice daily was shown to boost the level of tipranavir, and lowered the amount of virus in the blood — more than patients who took other currently available anti-HIV medicines.
The labeling for tipranavir will include a black box warning indicating the drug can cause serious liver problems, especially in patients with liver disease. Additional adverse events seen in clinical trials include skin rashes (seen more often in HIV-positive women as compared to HIV-positive men) and higher cholesterol and triglycerides levels.
Patients using tipranavir with low-dose ritonavir should report use of any other tipranavir drug, nonprescription, or herbal products, particularly St. John’s wort to their provider, due to potential drug interactions.
Certain medicines should never be given to patients taking tipranavir plus ritonavir because serious side effects that include antiarrhythmics, antihistamines, ergot derivatives, medicines that speed up the digestive tract, herbal products, some medicines that lower cholesterol levels, and medicines to treat mental problems.
Boehringer Ingelheim Pharmaceuticals will conduct additional post-marketing studies that will look at drug-drug interactions and see how tipranavir works in other people, such as patients taking HIV medicines for the first time, children, and HIV-1-positive women.
• Sildenafil citrate (Revatio) by Pfizer. The FDA has approved sildenafil citrate (Revatio) as a treatment for pulmonary arterial hypertension (PAH). Sildenafil citrate also is the active ingredient in Viagra. The FDA granted sildenafil citrate a priority review. The FDA approval was based on results of a large randomized, double-blind, placebo-controlled study involving 277 patients with PAH. The study measured the exercise capability of patients after 12 weeks of treatment.
Patients were randomized to receive sildenafil citrate 20 mg, 40 mg, or 80 mg three times a day or placebo. All three treatment groups showed highly significant improvements in the six-minute walk distance, the standard measure of efficacy in PAH trials, compared to patients who received placebo. No differences were observed among the sildenafil citrate doses studied — therefore, the approved dosage is limited to 20 mg three times daily.
Revatio is the first oral treatment for PAH to be approved for patients with an early stage of the disease, allowing physicians to treat patients earlier. It was generally well tolerated at all doses studied. The most common side effects were headache, dyspepsia, flushing, epistaxis, and insomnia.
The Revatio 20 mg pill is white and round to distinguish it from Viagra’s blue diamond-shaped pill for erectile dysfunction.
• Azithromycin extended-release (Zmax) by Pfizer. The FDA has approved azithromycin extended release (Zmax) for oral suspension, a one-dose-only treatment for mild-to-moderate acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) in adults.
Using microsphere technology, azithromycin extended release delivers a complete course of therapy in a single 2 g dose. In the first 24 hours after a dose of Zmax, the amount of drug that gets into the tissue is three times higher than a standard dose of immediate-release azithromycin. Immediate-release azithromycin has been available in the United States since 1992 under the trade name Zithromax. This "front loading" of azithromycin extended release provides high drug levels earlier in the course of infection when the bacterial burden is likely to be highest.
Azithromycin extended release offers a safety profile comparable to other antibiotic treatments for certain types of sinusitis and pneumonia and is generally well tolerated. Side effects generally were mild to moderate. Overall, in the pivotal studies the most common treatment-related adverse reactions in adult subjects receiving a single (2 g) dose of azithromycin extended release were diarrhea/ loose stools (11.6%), nausea (3.9%), abdominal pain (2.7%), headache (1.3%), and vomiting (1.1%).
Zmax is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any other macrolide or ketolide antibiotic.
•New indication for nitazoxanide (Alinia) by Romark Laboratories. The FDA has approved nitazoxanide (Alinia) tablets and oral suspension for treating diarrhea caused by Cryptosporidium parvum infection in adults and children 12 years and older. The product, already approved to treat the same infection in younger children, received a priority review by the FDA.
This is the third approval of an NDA for nitazoxanide within the past 31 months. Nitazoxanide now is indicated for treatment of diarrhea caused by Giardia or Cryptosporidium in patients 1 year of age and older. It is available as a tablet or a strawberry-flavored liquid to be taken orally twice daily for three days. Romark is continuing research to determine Alinia’s effectiveness in treating other important gastrointestinal diseases including Clostridium difficile-associated diarrhea and Crohn’s disease.
Tipranavir (Aptivus) by Boehringer Ingelheim Pharmaceuticals. The FDA has approved tipranavir (Aptivus) capsules, an HIV protease inhibitor, to be given with ritonavir for treatment of HIV-1-infected adults. This is the second drug approved for patients with advanced HIV disease.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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