New Drugs and Devices 2005

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Abraxane (Paclitaxel Protein-Bound Particles, Albumin Bound)

American Bioscience — Abraxane is a reformulated version of paclitaxel. The older product uses a solvent, Cremophor, which can produce serious allergic reactions while the Abraxane formulation is much less likely to produce an allergic reaction. In addition, the solvent in the older product can leach chemicals from plastic intravenous tubing requiring the use of special tubing whereas Abraxane can be administered using regular tubing. Therapeutic effectiveness should not be different between the older formulation and Abraxane.

Aczone (Dapsone)

QLT — This new topical preparation has been approved for the treatment of acne vulgaris. It is the first preparation of this drug to be applied topically. In clinical trials, Aczone use resulted in a significant reduction of the number of acne lesions. Side effects include: oiliness/peeling, dryness, and redness of the skin. Note: Aczone may increase hemolytic anemia in a subset of patients with a deficiency of glucose-6-dehydrogenase. Testing for this deficiency should be done prior to use of Aczone.

Ammonul (Sodium Phenylacetate and Sodium Benzoate)

Ucyclyd — This recently approved drug is indicated in the treatment of Urea Cycle Disease (UCD). Patients with UCD often have episodes of acute hyperammonemia (excess ammonia in the blood) with acute encephalopathy which is often life threatening. Ammonul is used as salvage therapy in acute cases and the survival of acute episodes treated with Ammonul is over 90% compared with 5% survival without Ammonul. To prevent the acute episodes, Ucyclyd also markets an oral drug, Buphenyl in tablet and powder form for ongoing pevention of acute episodes.

Aptius (Tipranavir)

Boehringer — This is another addition to the class of protease inhibitor drugs used for the treatment of HIV/AIDS. The chemical structure is somewhat different from the other protease inhibitors thus making it useful in treating HIV/AIDs which has become resistant to other available protease inhibitors. Like other AIDS treatment drugs, it should not be used alone and should be combined with Norvir ( Ritonavir) and at least two other anti HIV drugs each with a different mechanism of action.

Arranon (Nelarabine)

Glaxo — This is used to treat adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL), whose disease has not responded to or as relapsed following at least two chemotherapy regimens. *In one study of pediatric patients, 23% who were refractory to other treatments had a complete disappearance of their disease. This lasted from 3.3 to 9.3 weeks. Arranon kills cancer cells by blocking the cellis ability to reproduce. Common side effects are fatigue, nausea, vomiting and diarrhea.

Baraclude (Entecavir)

Bristol — Baraclude is an oral tablet taken once daily for the treatment of chronic hepatitis B infections in adults with evidence of continued active disease. In comparative studies using both viral load and liver function as endpoints, Baraclude was superior to the other approved drug, lamuvidine, in the treatment of chronic hepatitic B infections. It may also be useful in lamuvidine-resistant infections. Baraclude is a nucleoside analogue and interferes with viral replication. Side effects include: headache, tiredness, dizziness and nausea. The most significant but rare side effect is lactic acidosis and severe hepatomegly with steatosis.

Byetta (Exenatide)

Amylin — Byetta represents a new class of drugs for the treatment of diabetes with a pharmacology similar to that of GLP-1, a naturally occurring incretin hormone. Available as an injection, Byetta is indicated as adjunctive therapy to improve glucose control in Type 2 diabetics not adequately controlled on oral therapy. Retisert for chronic uveitis Retisert (Flucinolone actonide) – Bausch and Lomb – This newly approved drug has been approved for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye. It comes as a small pellet which is surgically inserted into the eye. Boostrix for whoop[ing cough Boostrix (Whooping cough vaccine) – Glaxo – This is first vaccine which will protect adolescents against pertussis (Whooping Cough). Although protection does result from the use of DPT vaccine it is believed that immunity induced by DPT decreases over time. Whooping cough cases in the U.S. increase from 10,000 in 2003 to 18,000 in 2004. Boostrix acts as a booster to adolescents who have received DPT as infants.

Boniva (Ibandronate)

Roche — Boniva is an oral tablet which has been approved for use in preventing osteoporosis in post-menopausal women. Although similar in pharmacology to other already approved medications for this use, Boniva can be taken once a month thus potentially improving patient compliance as compared with other similar drugs.

Exjade (Deferasirox)

Novartis — This is the first oral agent available in the United States for the treatment of iron overload. Prior to this, the only product available had to be given by injection. Side effects are mild to moderate and include; nausea, vomiting, diarrhea, abdominal pain, skin rashes, and an occasional increase in serum creatnine. Rarely, there have been reports of ocular (eye) and auditory disturbances.

Lyrica (Pregabalin)

Pfizer — Lyrica is for the treatment of neuropathic (nerve) pain associated with diabetes or herpes. Possible side effects include dizziness, tiredness, blurred vision, weight gain, difficulty with concentration/attention, ankle swelling, and dry mouth. The date of commercial availability in the U.S. is unknown, but the product is available in Europe.

Mycamine (Micafungin)

Astellas Pharma — This injectable drug is indicated for the treatment of esophageal fungal infections due to Canadida and to prevent systemic fungal infections in patients undergoing bone marrow transpantations. Side effects include: nausea/vomiting, headache, rash, and diarrhea.

Naglazyme (Galsulfase)

BioMarin — This is the first drug approved for the treatment of mucopolysaccharidosis VL (MPS VI). MPS VI is cause by a deficiency of the enzyme N-acetylgalactosamine 4-sulfatase which leads to an accumulation of glycosaminoglycans. The accumulation of glycosaminoglycans is believed to be responsible for the systemic effects of this disease. Naglazyme reduces the accumulation of the glycosaminoglycans and results in a significant improvement of symptoms of this disease in affected patients. Naglazyme restricted in availability in the USA to physicians and hospitals. A compassionate release program on a named patient basis is available for international patients.

Nexavar (Sorafenib)

Onyx/Bayer — This newly approved drug is indicated for the treatment of advanced renal cell carcinoma. It acts by inhibiting a variety of kinases notably, serine and threonine, which results in inhibition of tumor cell growth. In clinical trials, Nexavar doubled the progression-free (absence of tumor growth) survival time compared with placebo-6 months vs/3 months. Side effects which occurred in 31% of patients include: diarrhea, rash,fatigue,alopecia, hypertension and anorexia.

Orencia (Abatacept)

Bristol-Myers — is a new addition to drugs which are used to treat moderate to severe rheumatoid arthritis (RA). Similar to a number of other drugs in this class, it interferes with the inflammatory process responsible for the majority of pain and joint erosion seen with RA. It acts by binding to specific T-cell receptors thus preventing their activation and their participation in the inflammatory response. Concurrent use with the TNF antagonist class of agents used to treat RA should be avoided as that is associated with a high rate of infections with no benefit on the symptoms of RA. The most serious side effect is an increased incidence of infections with the most serious being pneumonia, cellulitis, urinary tract infections, bronchitis and diverticulitis.

Retisert (Flucinolone Actonide)

Bausch and Lomb — This newly approved drug has been approved for the treatment of chronic, non-infctious uveitis affecting the posterior segment of the eye. It comes as a small pellet which is surgically inserted into the eye.

Revatio (Sildenafil)

Pfizer — This is a new indication for sildenafil (Viagra in higher doses). It has been approved for the treatment of pulmonary hyperetension. Compared with placebo, there were significant increases in six-minute walk distance.

Revlimide (Lenalidomide)

Celgene — This drug has been approved for the treatment of myelodysplastic syndrome (MDS) associated with a cytogenic abnormality known as deletion 5Q. Patients with MDS do not make enough normal red blood cells leading to chronic anemia. They have to have repeated transfusions to be able to function normally. In this subgroup of patients, those treated with Revlimid no longer required transfusions with the transfusion-free period lasting 44 weeks. Because this drug is structurally related to thalidomide, distribution in the United States will be closely controlled requiring 1. An informed consent from each patient 2. female patients will be required to undergo mandatory pregnancy testing by their physician and 3. All prescribers must be registered with Celgene. In addition, prescriptions will be limited to a one month supply and any pregnancies occurring while a woman is taking Revlimide must be reported.

Rozerem (Ramelton)

Takeda Pharmaceuticals — The FDA has just approved Rozerem (Ramelton), a melatonin receptor agonist, for the treatment of insomnia. The 8mg dosage has been approved for chronic and acute insomnia. Melatonin is believed to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. Rozerem has not been designated as a controlled substance which will differentiate it from most modern sleep agents. Manufactured by Takeda Pharmaceuticals North America, Rozerem works by targeting two receptors, MT1 or MT2, in the suprachiasmatic nucleus, which controls circadian rhythms. Rozerem should be taken one-half hour proir to bedtime. The drug is generally well tolorated with most common side effects being somnolence, fatigue, and dizziness. Rozerem is metabolized by the liver, and so should be used cautiously by patients with severe hepatic impairment. The company said patients taking Luvox (Fluvoxamine) should not take Rozerem. Patients with depression should also be closely monitored because of potential to exacerbate symptoms.

Symlin (Pramlintide)

Amylin — This new injecatble drug is an Analogue of amylin. Amylin and insulin both work together to increase the utilization of glucose by the cell thus reducing elevated blood glucose levels. It is indicated for the treatment of patients who have a difficult time controlling blood glucose levels immediately after a meal. Side effects include: hypoglycemia (low blood sugar) especially during the first weeks of therapy, nausea and vomiting. All of these side effects lessen with continued therapy.

Tygacil (Tegecycline)

Wyeth — this new injectable antibiotic has been approved for the treatment of systemic infections due to multi-drug resistant organisms including staphlococcus aureus. It is the first of a class of antibiotics called glycylcyclines. It is structurally related to minocycline. Its mechanism of action appears to be mediated through interferance with bacterial ribosomeal mediated protein production. Side effects appear to be less than those of other antibiotics used to treat resistant infections. In one study, clinical efficacy in complicated skin and structure infections Tygacil produced a 74% cure rate.

Zyflo (Zileuton)

Critical Therapeutics — This drug originally approved in 1996 and marketed by Abbott was withdrawn from the market in 2004. Zyflo is a specific inhibitor of 5-lipoxygenase and thus inhibits leukotriene (LTB4, LTC4, LTD4, and LTE4) formation. These mediators are important in bronchial inflammation which precipitates asthmatic attacks.