FDA approves Vertex for phase III telaprevir study
CAMBRIDGE, Mass. Vertex Pharmaceuticals has received approval from the Food and Drug Administration to conduct phase III studies of its hepatitis C drug telaprevir, according to published reports.
The company will conduct two phase III trials to satisfy FDA regulations. The first study will enroll 1,050 patients with newly diagnosed hepatitis C and will evaluate two different telaprevir regimens, each totaling 24 weeks in length. The patients will be compared to patients treated with the current standard of care for 48 weeks.
The second, smaller study will test a telaprevir-containing regimen that lasts 48 weeks, again compared to a 48-week standard of care. This study will enroll between 400 and 500 newly diagnosed hepatitis C patients.
Both studies will run concurrently, with enrollment forecast to be completed by the end of the year. Vertex said it expects results from both studies should be ready for release in the middle of 2010. If positive, Vertex could seek FDA approval of telaprevir by the end of 2010, with an approval decision likely in mid-2011.
Telaprevir is a pill designed to attack hepatitis C by inhibiting the protease enzyme, one of the key enzymes the virus uses to copy itself. This “direct antiviral” approach differs from current hepatitis C drugs, which boost the immune system’s ability to tamp down and eliminate the virus.
FDA halts clinical trial of ALS drug
LOS ANGELES The Food and Drug Administration has told CytRx to stop its clinical trial of the drug arimoclomol, which is being developed to treat amyotrophic lateral sclerosis, or Lou Gehrig’s disease, because of the need for additional analysis of previous animal studies involving the drug, according to published reports.
CytRx said in a release that it has asked for further clarification from the FDA, and said that “arimoclomol has been shown to be safe and well-tolerated after being administered to about 185 study volunteers.”
ALS is a progressive condition that affects nerve cells in the brain and spinal cord.
Study indicates that drive-through can distract pharmacists
COLUMBUS, Ohio A new study in the International Journal for Quality in Health Care has indicated that pharmacists who work at stores with drive through windows are more likely to be distracted and those distractions can lead to processing delays, reduced efficiency and even dispensing errors.
The pharmacists who were surveyed reported that the design and layout of their workplaces has an impact on dispensing accuracy, especially the presence of drive-through window pick-up services. Results also indicate that automated dispensing systems in pharmacies are likely to reduce the potential for errors and enhance efficiency.
Even with stringent internal quality controls, pharmacists nationally make an estimated 5.7 errors per 10,000 prescriptions processed, according to the study, which translates to more than 2.2 million dispensing errors each year.
According to the survey, pharmacists perceive that the drive-through window has the biggest impact on causing pharmacists and their staff to take extra steps (average agreement response of 3.7 on a 5-point scale); reducing efficiency (average response of 3.8); and causing delays in prescription processing (average response of 3.7). The respondents also attributed dispensing errors (average response of 3.2) and communication errors (average response of 3.3) to the presence of a drive-through window.
“A pharmacist or staff member could be responsible for four or five tasks, and serving people at the drive-through window is just one of them,” said Sheryl Szeinbach, the study’s lead author. “Some people seeking the convenience of the drive-through window don’t care about getting information. They just want the medication, and they want it as fast as possible. They should probably think about that and at least look at the medication and make sure it’s OK. And if they have questions, it may behoove them to come into the pharmacy.”