What’s Emerging on the Market and Under the Microscope?

December 31, 2006

The FDA has approved injectable Acetadote (acetylcysteine)from Cumberland Pharmaceuticals Incto prevent or lessen liver damage resulting from an overdoseof acetaminophen. According to the FDA, unintentionalacetaminophen overdose is responsible for 100deaths and 56,000 emergency department visits per year.

First Injectable Treatmentfor Acetaminophen ToxicityThe FDA has approved injectable Acetadote (acetylcysteine)from Cumberland Pharmaceuticals Incto prevent or lessen liver damage resulting from an overdoseof acetaminophen. According to the FDA, unintentionalacetaminophen overdose is responsible for 100deaths and 56,000 emergency department visits per year.For maximum efficacy, Acetadote should be administeredimmediately or within 8 hours of the acetaminophenoverdose. Efficacy is diminished at 8 hours postingestion,and the drug's effect is limited between 15 and 24 hourspostingestion.Acetadote must be used with caution in patients witha history of asthma or bronchospasm. In one Australianstudy of this agent, one patient with asthma died and 17%of all patients experienced serious anaphylactoid reactionsin the first 2 hours after administration.Orthovisc Manages OsteoarthritisKnee PainOrthovisc, from Anika Therapeutics, Inc, has recentlybeen approved by the FDA to manage knee paincaused by osteoarthritis. The highly purified, high molecularweight form of hyaluronic acid has been used internationallysince 1996.Orthovisc is injected directly into the knee joint. Itis indicated in patients with mild to moderate knee osteoarthritiswhose pain does not respond to nonpharmacologictherapy and simple analgesics. Full efficacy isachieved after 3 weekly treatments: pain relief may lastup to 6 months.Combination Drug to TreatHypertension and HyperlipidemiaThe FDA has approved Caduet, a combination ofNorvasc (amlodipine besylate) and Lipitor (atorvastatincalcium), from Pfizer Inc. Caduet is indicated forthe concurrent treatment of high blood pressure and highcholesterol levels.The drug is available in 2 doses of Norvasc, 5 and10 mg; and 10, 20, 40, or 80 mg of Lipitor. The startingand maintenance doses of Caduet are tailored to the individualpatient for the treatment of hypertension or anginaand hyperlipidemia. Liver function tests are recommendedbefore and after 12 weeks of therapy or when the dosageis increased. Follow-up is indicated at regular intervalsthereafter.Caduet is contraindicated in patients with liver disease,unexplained persistent elevations of serum transaminaselevels, and pregnant or nursing women. Statins have beenassociated with the development of myopathy; therefore,patients need to be advised to report unexplained musclepain, tenderness, or weakness.Monoclonal Antibody Approvedfor Advanced Colorectal CancerThe FDA has approved Erbitux (cetuximab) fromImClone Systems Incorporated and Bristol-MyersSquibb Company. It received a priority review under theFDA's accelerated program for drugs that treat cancer orlife-threatening diseases, although it has not been shownto extend patients' lives.Erbitux is used in patients with epidermal growth factorreceptor-expressing metastatic colorectal cancer.The drug is administered intravenously, either alone in patientswho cannot tolerate irinotecan (a chemotherapydrug used to treat colorectal cancer) or in combinationwith irinotecan for patients whose disease is refractory toirinotecan-based chemotherapy. The combination of Erbituxand irinotecan was shown to shrink tumors in 22.9%of patients and delay tumor growth by approximately4.1 months. Erbitux alone shrank tumors in 10.8% of patientsand delayed tumor growth by 1.5 months.Serious side effects are most likely to occur duringinitial treatment and include difficulty in breathing andhypotension.Transdermal Estrogen TherapyTreats Menopausal SymptomsEstroGel (estradiol gel) from Solvay Pharmaceuticals,Inc, has been approved to treat severe vasomotorsymptoms and vulvar and vaginal atrophy associatedwith menopause. Available for 25 years in Europe, Estro-Gel is the first transdermal gel estrogen therapy availablein the United States.EstroGel is administered with a metered-dose pumpthat delivers 1.25 g of gel and is applied once daily on asingle arm from wrist to shoulder. It avoids first-passmetabolism in the liver and is associated with a lower incidenceof skin irritation than transdermal estrogenpatches.Contraindications to estrogen therapy include breastcancer, known or suspected pregnancy, active thrombophlebitis,and thromboembolic disorders.Once-Daily Treatmentfor COPDSpiriva HandiHaler (tiotropium bromide inhalationpowder) has been approved by the FDA for thetreatment of bronchospasm associated with chronic obstructivepulmonary disease (COPD). Developed byBoehringer Ingelheim, the drug will be co-promoted inthe United States by Pfizer Inc.Spiriva is an anticholinergic drug designed to be usedonce a day as a long-term maintenance therapy. It mayexacerbate symptoms of glaucoma and prostatic hyperplasiaand must be used with discretion in patients with thoseconditions. Spiriva needs to be inhaled at the same timeeach day in a dose of 18 μg.Symbyax Approved forBipolar DepressionThe FDA has approved Symbyax (olanzapine andfluoxetine) from Eli Lilly and Company for managementof the depression phase of bipolar disorder. A combinationof the active ingredients from Zyprexa and Prozac,Symbyax is the first drug approved for bipolar depression.Because atypical antipsychotics are associated withhyperglycemia, all patients must be monitored for glucoseabnormalities. Patients at risk for diabetes should receivea baseline fasting blood glucose test before starting therapy;periodic monitoring is recommended thereafter.