FWD:RSD World News-FDA has approved Prialt Intrathecal Infusion for Chronic Pain

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From: byrd45 (Original Message) Sent: 10/12/2006 9:59 AM
The U.S. Food and Drug Administration (FDA) has approved ziconotide intrathecal infusion for the non-narcotic management of refractory severe chronic pain; clofarabine for the treatment of refractory or relapsed pediatric acute lymphoblastic leukemia (ALL); mometasone furoate monohydrate nasal spray for the treatment of nasal polyps; and a six-month formulation of leuprolide acetate for the palliative treatment of advanced prostate cancer.

Non-Narcotic Ziconotide Intrathecal Infusion (Prialt) for Severe Chronic Pain

On Dec. 28, the FDA approved ziconotide intrathecal (IT) infusion (Prialt, made by Elan Corporation, plc), for the management of severe chronic pain in patients for whom IT therapy is warranted, and who are intolerant or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

The non-narcotic agent is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus, and is thought to work by blocking N-type calcium channels on nerves that transmit pain signals.

The approval was based on the results of three phase 3 clinical trials showing that ziconotide IT significantly reduced chronic pain in a variety of opioid-resistant patient populations with neuropathic pain and pain related to cancer and AIDS.

Adverse events were mild to moderate in intensity and included dizziness, ataxia, confusion, and abnormal gait.

Ziconotide IT is approved for use only in the Medtronic SynchroMed EL, SynchroMed II Infusion System, and Simms Deltec Cadd Micro External Microinfusion Device and Catheter.

Clofarabine (Clolar) for Refractory Pediatric Acute Lymphoblastic Leukemia (ALL)

On Dec. 28, the FDA granted an accelerated approval of clofarabine (Clolar, made by Genzyme Corporation)<WBR>, for the treatment of refractory or relapsed acute lymphoblastic leukemia (ALL) in pediatric patients aged 1 to 21 years and having failed at least 2 prior regimens.

The approval was based on the results of a phase 2 trial showing that clofarabine therapy induced a 30% response rate in pediatric patients who had failed an average of 3 prior treatment regimens. Of these, 20% achieved complete remission (CR) or complete marrow remission in the absence of platelet recovery (CRp), and 10% achieved a partial response (PR).

Dosing in the study consisted of 2 to 6 cycles of clofarabine 52 mg/m2 administered intravenously over a period of 1 to 2 hours daily for 5 consecutive days.

Adverse events included gastrointestinal tract symptoms (vomiting, nausea, diarrhea), hematologic effects (anemia, leucopenia, thrombocytopenia, neutropenia, febrile neutropenia)<WBR>, and infection.

Clofarabine was previously granted orphan drug status for adult and pediatric ALL. Its use in relapsed or refractory pediatric acute myeloid leukemia (AML) is currently being investigated.

Mometasone Nasal Spray (Nasonex) Approved for Treatment of Nasal Polyps

On Dec. 15, the FDA approved a new indication for mometasone furoate monohydrate nasal spray (Nasonex, made by Schering-Plough Corporation)<WBR>, allowing its use in the first-line treatment of nasal polyps in adults aged 18 years and older. A 200-mcg twice-daily dose is recommended, though a 200-mcg once-daily regimen may be effective in some patients.

According to a company news release, it is the first and only inhaled steroid approved for pre-surgical treatment of this condition.

The approval was based on the results of 2 controlled trials involving 664 patients that were randomized to receive mometasone 200-mcg nasal spray once- or twice-daily, or placebo.

Patients treated with a twice-daily regimen of mometasone nasal spray showed a statistically significant reduction in polyp grade in both studies. The once-daily regimen was likewise effective in one of the studies, showing only a numerical reduction in polyp grade in the other.

Both dosage regimens of mometasone nasal spray significantly reduced congestion, compared with placebo. Adverse events were generally mild and included headache, viral infection, sore throat, nosebleeds, and coughing.

The European Union's Mutual Recognition Procedure (MRP) was completed for this indication on Nov. 24, allowing its use in 13 European countries.

Mometasone furoate monohydrate nasal spray was previously approved by the FDA for the prevention of seasonal allergy symptoms in patients aged 12 years and older, and for the treatment of nasal allergy symptoms in patients aged 2 years and older.

Six-Month Formulation of Leuprolide Acetate Implant (Eligard) for Prostate Cancer

On Dec. 14, the FDA approved a 6-month formulation leuprolide acetate (Eligard 45-mg, made by QLT for Sanofi-Synthelabo Inc.), for the palliative treatment of advanced prostate cancer.

Sustained levels of the leuteinizing hormone-releasing hormone (LHRH) agonist decreases testosterone levels, suppressing tumor growth and reducing symptoms of hormone-responsive prostate cancer.

One-, 3-, and 4-month formulations of leuprolide acetate were approved by the FDA for this indication in 2002 and 2003. One- and 3-month formulations were approved for this indication by the European Commission (EC) on Dec. 21 for use in the European Union (EU).

Reviewed by Gary D. Vogin, MD


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