New Drugs and Devices 2000

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Acova (Argatroban)

Smith, Kline, Beecham - Acova is indicated for the treatment of heparin-induced thrombocytopenia (HIT). This condition affects approximately over 3% of patients who receive heparin therapy for preventing and treating blood clots (thrombosis). If left untreated , those who develop HIT can develop pulmonary emboli (lung clots), heart attacks or occlusion of a major artery supplying blood to an extremity with subsequent damage requiring amputation. Bleeding is the most serious side effect occurring in 2-3% of patients receiving Acova.

Actimmune (New Indication)

This drug which is interferon gamma 1b has been available since 1990 for the treatment of infections associated with severe granulatomous disease.

Actonel (Risendronate)

Procter & Gamble - Actonel is indicated in the treatment of degenerative bone disease in postmenopausal women. This drug can significantly reduce the incidence of both hip and vertebral fractures. It is similar in pharmacology to Fosamax but may have a lower incidence of gastrointestinal side effects.

Advair (Salmeterol and Fluticasone)

Glaxo - This new inhalation product combines a bronchodilator (salmeterol) with a anti-inflammatory steroid (fluticasone). Together they provide comprehensive approach to preventing asthmatic attacks. The combination product may be easier to use compared with multiple prophylactic regimen and less acute asthmatic attacks. It is NOT indicated in the treatment of an acute attack.

Androgel (Testosterone gel)

This new product for men is applied topically is indicated for the treatment of reduced libido, impotence, loss of energy and muusculature, and decreased bone density. When applied once daily 87% of hypogonadal men achieved normal testosterone levels and sexual desire, bone mineral density and lean body weight both increased.

Cafcit (Caffeine Citrate)

Roxane - Cafcit has been approved for the treatment of apnea of prematurity. This drug stimulates respiration in infants whose lungs are not fully developed. It is used to reduce the occurrence of episodes of cessation or reduced respiration (apnea) in these babies which will hopefully lower the need for supplemental oxygen. On day 2 after birth, the incidence of apnea in Cafcit treated infants was 75% compared with 92% in placebo treated infants.

Evoxac (Cevimeline)

Snowbird Pharmaceuticals - this new agent is the second drug to win FDA approval for the salivary deficiency experienced by patients with Sjorgren's Syndrome. It acts by stimulating muscarinic receptors which results in increased secretions from exocrine glands such as the salivary glands. Side effects include: Headache (14%), nausea (14%), runny nose (11%), respiratory tract infection (11%) and increased sweating (19%)

Exelon (Rivastigmine)

Novartis - Exelon, which has been available in Europe for some time, is indicated for the treatment of Alzheimer's disease. The mechanism of action is similar to Aricept and Cognex, both of which act to increase brain levels of acetylcholine, a critical brain neurotransmitter. After 26 weeks of therapy, 81% of patient either showed improvement in cognitive function or had a slower decrease in deterioration than did those taking a similar looking placebo (capsule).

Kaletra (Lopinavir and Ritonavir)

Abbott - this newly released drug is indicated for the treatment of HIV infections. The medication combines two protease inhibitors with the ritonavir (Norvir) added to slow the metabolism of the primary drug, lopinavir. Kaletra can be given two times a day, a dose schedule which could improve patient adherence to the triple therapy regimen. In one study, 83 of 100 patients had undetectable levels of HIV virus after 96 weeks in the study.

Mobic (Meloxicam)

this new drug is similar in action to Celebrex and Vioxx and is indicated for the treatment of pain associated with osteoarthritis. Side effects include: gastrointestinal upset, nausea.

Mylotarg (Gemtuzumab zogamicin)

Wyeth-Ayerst - Myelotarg is novel medication indicated for the treatment of relapsed adult acute myelocytic leukemia. This novel drug combines a specific antibody, CD33, with a chemotherapeutic drug (zogamicin). Specifically, the antibody attaches to the CD33 antigen found on leukemic cells which then delivers a toxic dose of zogamicin to the cancer cells. In trials, 26% of patients who no longer responded to conventional chemotherapy went into remission after Mylotarg. The relatively specific targeting of the leukemic cells reduces the toxicity to other non-target cells and reduces side effects significantly.

Pacis BCG, Live

Pacis is a form of Bacillus Calmette-Guerin (BCG) which has been approved for the immunotherapy of carcinoma in situ of the urinary bladder. The recommended course of therapy is a single dose given once weekly for six weeks. Manufacturer BioChem Pharma, USA distributor UroCo.

Precedex (Dexmedetomidine)

This is a new agent given intravenously for the postoperative use in an intensive care environment. It produces both sediation and analgesia without any accompanying respiratory depression.

Prevnar (Pneumococcal 7-Valent Conjugate Vaccine)

Prenvar is indicated for the prevention of pneumococcal respiratory tract infections in children under 5 years and immunocomprised individuals. The vaccine was found to be 100% effective in preventing infections caused by 7 of the pneumococcal serotypes which produce 80% of acquired pneumococcal pneumonia in those at risk.

Protonix (Pantoprazole)

This new oral drug is indicated for the short term treatment of gastroesophageal reflux which can lead to erosive esophagitis. This medication which will be available in the 2nd quarter of 2000. It is similar in pharmacology to Prilosec and Prevacid thus its only advantage over the other two drugs will be if it is less expensive.

Refacto

This is a genetically altered factor VIII which is used to prevent bleeding episodes in patients with hemophilia A who are undergoing surgery. It is also indicated for short-term routine prevention and reduction of spontaneous bleeding.

Targretin Gel (Bexarotene)

Ligand - This new topical agent is indicated for the treatment of early stage cutaneous T-cell lymphoma (CTCL). It is indicated when the disease has proven refractory to other therapies or those who have not tolerated other therapies. Side effects are mild and include: rash, itching, and pain. This topical treatment compliments the availability of oral Targretin capsules.

TNKase (Tenecteplase, Recombinant)

Genentech - this newly approved drug is indiciated for the treatment of acute myocardial infarction. It has an advantage over previous formulations of TPA (tissue plasminogen activator) in that it can be given as a single intravenous bolus dose instead of requiring infusions. Although the onset of action may be more rapid there was no statistical difference in mortality outcome between TNKase and the comparable infusion drug.

Trileptal (Oxcarbazepine)

This newly released antiepileptic drug (AED) is indicated for the treatment of partial seizures in adults and as adjunctive therapy along with other AEDS for children aged 4-14 years. In one clinical trial, 12% of patients who had failed on other therapies became seizure-free on Trileptal and a decrease in seizure frequency occurred in 50% of the others treated. Side effects include: dizziness, fatigue, dizziness and blurred vision. A small % experienced low serum sodium levels thus serum sodium levels need to be determined periodically while on Trileptal therapy. Approximately 1/3 of those allergic to carbamazepine (Tegretol) will also be allergic to Trileptal.

Trisenox (Arsenic Trioxide)

Cell Therapeutics - this newly approved drug injectable drug is indicated for the treatment of acute promyelocytic leukemia (APL). The complete response rate in patients with previously treated APL is an impressive 70%. Side effects include fatigue, fever, nausea, vomiting (58%), and decrease in blood potassium which occur in up to 50% of treated patients.

Trizivir (Abacavir, Lamuvidine, Azidothymidine, AZT)

This new product combines 3 medication "cocktail" (two reverse transcriptase inhibitors and one protease inhibitor) which are used to treat infections due to the human immunodeficiency virus (HIV, AIDS). The combination has the potential to substantially increase patient adherence to the drug regimen by decreasing the number of tablets taken each day to two (one tablet two times a day). The only negative about the combination is that the protease inhibitor abacavir, can produce a severe rash requiring discontinuation of therapy in 5% of patients taking the combination.

Vaniqa (Eflonithine)

Bristol - this topical agent is indicated for the treatment of excess facial hair in women. Vaniqa is applied topically and prevents hair growth rather than removing it after it is visible. Use of Vaniqa for 24 weeks resulted in improvement in reduction of facial hair in 60% of women who applied it daily. Side effects were rare and mild consisting of transient redness, burning, and tingling of the skin.

Zemplar (Paricalcitol)

Abbott - Zemplar has been approved for the treatment of hyperparathyroidism. Zemplar is a synthetic vitamin D analogue which suppresses parathyroid hormone production with a minimal effect on calcium and phosphorous. Side effects are rare and consist of nausea, vomiting, and diarrhea.

Zonegran (Zonisamide)

This new drug has been approved for adjunctive treatment of partial (focal) epilepsy in adults. There was a 25% reduction in seizure frequency . The major side effect is sedation (17%). An unusual side effect is that this drug produces kidney stones in 4% of those taking it and a high fluid intake is recommended to prevent this side effect. Zonegran for partial seizures in adults.