FDA Drug and Device Approvals: Zelnorm, Taxotere, Merci Retriever, and Others

Yael Waknine

August 26, 2004

Aug. 26, 2004 — The U.S. Food and Drug Administration (FDA) has approved tegaserod maleate for chronic idiopathic constipation, docetaxel in combination with doxorubicin and cyclophosphamide for node-positive breast cancer, and loratadine/pseudoephedrine sulfate for congestion due to the common cold. A device for removing thromboemboli in stroke patients (Merci Retriever) and a workstation to enhance breast imaging (Impax Mammography Diagnostic Workstation) have also been approved.

Tegaserod Maleate (Zelnorm) for Chronic Idiopathic Constipation

On Aug. 23, the FDA approved a supplemental indication for tegaserod maleate (Zelnorm, made by Novartis Pharmaceuticals Corp.), allowing its use in the treatment of chronic idiopathic constipation in patients younger than 65 years.

The approval was based on the results of two 3-month, randomized, double-blind, placebo-controlled, multinational phase III clinical trials involving more than 2,600 patients. Tegaserod was found to significantly increase the frequency of complete spontaneous bowel movements and provide relief from symptoms such as straining, hard stool, incomplete evacuation, infrequent defecation, bloating, and abdominal discomfort.

Adverse events included transient diarrhea lasting two days that generally resolved without rescue medication or treatment interruption. A 13-month extension safety study showed tegaserod to be safe and well-tolerated with long-term use.

Tegaserod was previously approved by the FDA in July 2002 for the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation. It is currently under study for use in gastroesophageal reflux disease and dyspepsia.

Docetaxel (Taxotere) as Adjuvant in Treatment of Node-Positive Breast Cancer

On Aug. 18, the FDA approved a supplemental indication for docetaxel (Taxotere, made by Aventis Pharmaceuticals), allowing its use in combination with doxorubicin and cyclophosphamide in the adjuvant treatment of operable node-positive breast cancer.

Docetaxel was previously approved in the treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy, locally advanced or metastatic non-small cell lung cancer, and prostate cancer.

Loratadine/Pseudoephedrine (Claritin-D) for Congestion Due to Colds

On July 30, the FDA approved a supplemental indication for loratadine/pseudoephedrine sulfate (Claritin-D 12 Hour and Claritin-D 24 Hour Extended Release tablets, made by Schering-Plough Healthcare Products), allowing its use for the temporary relief of nasal congestion due to the common cold in adults and children aged 12 years and older.

Loratadine/pseudoephedrine was previously approved for the temporary relief of congestion and other symptoms caused by hay fever and other upper respiratory allergies.

Corkscrew Device (Merci Retriever) Removes Thromboemboli in Stroke Patients

On Aug. 16, the FDA approved a corkscrew device (Merci Retriever, made by Concentric Medical) for use in removing thromboemboli from the brain in patients experiencing an ischemic stroke.

The device, inserted by catheter into the femoral artery and maneuvered to the brain via the carotid artery, is deployed just beyond the occlusive thrombus, capturing it with a tiny corkscrew for retrieval. Blood flow can be restored in as few as 20 minutes compared with standard thrombolytic therapy that must be given within three hours and may require two hours to take effect.

The approval was based on a review of data obtained in the multicenter Mechanical Embolus Removal in Cerebral Ischemia (MERCI) trial that involved 141 patients ineligible for standard thrombolytic therapy.

According to a company news release, trial data show a mortalityrate for the device of 38%. Successful clearing of a thrombus reduced mortality by half compared with unsuccessful attempts. Risks associated with use include hemorrhaging and vessel punctures.

The device has received the CE Mark in Europe and is approved for use in Canada.

Workstation (Impax Mammography Diagnostic Workstation) Enhances Diagnostic Efficiency of Breast Imaging

On July 29, the FDA approved a workstation (Impax Mammography Diagnostic Workstation, made by Agfa Corp.) for digital breast-imaging studies and to gain access to other general imaging examinations.

The digital workstation includes ultra–high resolution, high-contrast monitors, a number of image manipulation tools, specialized diagnostic and workflow automation tools, and the capacity to simultaneously review multimodality images such as those from ultrasound.

The workstation is capable of full integration with PACS, RIS, HIS, and reporting applications.

According to a company news release, the workstation represents a digital solution to streamline workflow and improve access as well as provide faster results and an improved patient-care continuum.

Reviewed by Gary D. Vogin, MD

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