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October 23, 2008 — The US Food and Drug Administration (FDA) has approved quetiapine fumarate extended-release tablets for the treatment of manic and depressive episodes associated with bipolar disorder, a deltoid site of administration for risperidone long-acting injection, and a C1-esterase product for the prevention of hereditary angioedema attacks.
Once-Daily Quetiapine Fumarate (Seroquel XR) Approved for Bipolar Disorder
On October 8, the FDA approved new indications for quetiapine fumarate extended-release tablets (Seroquel XR; AstraZeneca), allowing its use for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
The approval for bipolar depression was supported by data from a placebo-controlled study of 280 acutely depressed adults with bipolar I or II disorder, showing that once-daily quetiapine therapy yielded significant improvements from baseline in the Montgomery Asberg Depression Rating Scale total score after 8 weeks of treatment (–17.4 vs –11.9; P < .001), with significant decreases in total score at week 1.
Approval of the bipolar mania indication was based on data from a randomized, placebo-controlled study (n = 316), showing that once-daily quetiapine was significantly more effective for achieving symptom improvement, as assessed by mean change in the Young Mania Rating Scale (YMRS) total score at week 3 (–14.3 vs –10.5; P < .001). According to a company news release, the reduction in YMRS was significant vs placebo at day 4.
In these studies, doses of extended-release quetiapine administered for bipolar mania (400 - 800 mg/day) and depression (300 mg/day) yielded comparable results to the FDA-approved recommended doses for immediate-release quetiapine for those indications.
"In these two studies quetiapine XR provided a reduction in symptoms for patients with bipolar disorder across mixed, manic and depressive episodes," said professor Patricia Suppes, from Southwestern Medical School in Houston, Texas. "That is encouraging for patients and physicians alike as a single medication that if approved can address the spectrum of mood episodes in bipolar disorder as a once-daily monotherapy is an attractive idea."
The approvals also provide for the use of the previously approved (but not marketed) 50-mg tablet for initiation of dose titration at a lower starting dose.
Extended-release quetiapine previously was approved for the acute and maintenance treatment of schizophrenia.
Long-Acting Risperidone (Risperdal Consta) Deltoid Injection Site Approved
On October 8, the FDA approved a new site of administration for risperidone long-acting injection (Risperdal Consta; Janssen LP [a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc]), allowing its injection into the deltoid muscle for the treatment of schizophrenia.
The approval was based on study data showing that deltoid and gluteal injections of the drug were bioequivalent (and therefore interchangeable), with similar safety and tolerability profiles.
"For many patients, this injection site may be a good option, as it will provide them with a choice of where to receive their long-acting therapy," said Dr. Mohammed Bari, of Synergy Research Center in San Diego, California, and one of the study investigators, in a company news release. "The fact that they will just have to roll up their sleeves and get the shot in their arm is going to be a big plus for many patients with schizophrenia."
New risperidone dose packs containing 2 separate (not interchangeable) needles for injection are expected to be available by the end of 2008.
C1-Esterase Inhibitor Infusion (Cinryze) to Prevent Hereditary Angioedema Attacks
On October 10, the FDA approved a C1-esterase inhibitor product derived from human plasma (Cinryze; Lev Pharmaceuticals, Inc) for routine prophylaxis against angioedema attacks in adolescents and adults with hereditary angioedema (HAE).
HAE is a rare, severely debilitating, and life-threatening condition that affects 6000 to 10,000 individuals in the United States and is caused by a hereditary C1-esterase deficiency.
According to an FDA news release, it is the first product licensed for this indication in the United States. "Cinryze should greatly enhance treatment options for those with hereditary angioedema and potentially save lives," noted Jesse Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research.
The approval was based on data from a 12-week phase 3 crossover clinical trial of 24 patients, showing that prophylactic use of the product significantly (P < .0001) decreased the number of attacks per patient by more than half relative to placebo (mean number of attacks, 6.1 ± 5.4 vs 12.7± 4.8; median number of attacks, 6 vs 13.5; number of attacks, 0 - 17 vs 6 - 22).
Significant improvements were also observed with respect to secondary endpoints, including a 66% reduction in the mean number of days of swelling (10.1 vs 29.6 days; P < .0001), decreases in the average severity of attacks (scored from 1 - 3: 1.3 vs 1.9; P = .0006), and decreases in the average duration of attacks (2.1 vs 3.4 days; P = .0023).
The C1-esterase inhibitor product is administered intravenously (40 units/mL; 1000 units/dose, at a rate of 1 mL/minute) and can be used every 3 or 4 days. Adverse events most commonly reported in clinical studies have included upper respiratory tract infection, sinusitis, rash, and headache; no serious drug-related events were observed.
According to a company news release, 2 open-label studies are being conducted as part of the C1 inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy trials; more than 9000 doses have been administered thus far, with more than 12 patients having individually received well more than 200 doses.
Seroquel XR Prescribing Information
Risperdal Consta Prescribing Information
Cinryze Prescribing Information
