New Drugs and Devices 2001

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New Device for diabetes from Novo-Nordisk

This new device will display on a miniature screen the dose and time since the last injection. It will also perform the injection of a predetermined dose. By providing a record of the doses administered it will make compliance with an insulin regimen easier to follow.

Abreva (Docosanol)

This newly approved topical medication for fever blisters does not require a prescription! It is rare we will announce a non-prescription drug approval but this is significant. Application early in the evolution of the fever blister both significantly shortens symptom duration and speeds healing time.

Angiomax (Bivalirudin)

The Medicines - this a thrombin-specific IV anticoagulant. It is indicated as a replacement for heparin when excess bleeding and thrombosis is anticipated to be a problem with heparin. It is to be used along with aspirin. When compared with heparin in patients undergoing percutaneous transluminal coronary angioplasty Angiomax had a significantly lower incidence of ischemic complications and of major hemorrhage and a lower need for transfusions.

Campath (Alemtuzumab)

Berlex Campath is a new injectable drug indicated for the treatment of refractory B-cell chronic lymphocytic leukemia (B-CLL). It targets the CD52 receptor on the B-lymphocyte (as well as B-lymphocytes and certain other cells). The union of receptor and antibody results in cell lysis and destruction. It can produce objective responses in approximately 30% of treated patients who have become resistant to other drugs used for B-CLL. Side effects are significant with infusion related events occurring in 6% of patients, rigors in 86%, hypotension in 32%, nausea (54%), and depression of white (85%) and red blood cells (80%).

Cancidas (Caspofungin)

Merck - Cancidas is the first drug of a class known as glucan synthetase inhibitors. This new drug is given intravenously and is indicated for the treatment of systematic invasive aspergillosis. The mean duration of therapy was 34 days at a dose of 50 mg daily. At this dose approximately 50% of patients responded to treatment. Side effects were rare (<2%) and limited to fever, nausea and vomiting.

Entocort EC (Budesonide)

AstraZeneca - Entocort is an oral steroid recently approved for use in the treatment of Crohn's disease. The advantage of this preparation over other oral steroids is its formulation. The capsule delays the release of the steroid until it reaches the small intestine. This allows the use of a smaller dose than otherwise if it had to act systematically instead of locally. In addition the lower dose significantly reduces the incidence of side effects.

Geodon (Ziprasidone)

Pfizer - Geodon, an oral medication, is indicated for the treatment of schizophrenia. It acts as a serotonin and dopamine antagonist. It represents a significant advance in an area where the number of effective drugs is limited. Its major advantage over other drugs used for schizophrenia is the absence of weight gain or development of type II diabetes as side effects. The most common side effects are: headache, abnormal movements, nausea, and constipation.

Gleevec (Imatinib)

Novartis - This is a revolutionary new drug indicated for the treatment of chronic myelogenous leukemia. This drug which is taken once a day by mouth acts by preventing production of an abnormal protein which is involved in the proliferation of the cancerous white blood cells. Side effects are surprisingly minimal and consist of abdominal discomfort, bone and joint pains and tiredness. The success rate in newly diagnosed cases resistant to Interferon is 90%. Its value in later stages and its ability to maintain remissions is unknown. This drug is known as Glivec in Europe and elsewhere.

Kineret (Anakinra)

Amgen - Indication: Rheumatoid arthritis (RA). This is a new addition to the two injectable drugs currently available to treat RA, Enbrel and Remicade. Kineret interferes with the inflammatory response by blocking interleukin-1. It is only moderately effective with only 38% of patients showing a 20% improvement in 6 months compared with 20% of patients on placebo injections. Side effects include redness, welling and pain at the injection site.

Myobloc (Botulinum Toxin Type B)

Elan - this new drug has been approved for use in the symptomatic treatment of cervical dystonia. Cervical dystonia is a painful condition in which the neck and shoulder muscles have contractions which force the neck and head into unusual and painful positions. Myobloc acts by interrupting nerve impluse transmission between the nerve and its respective muscle. The duration of a positive response was 12-16 weeks.

Natrecor (Nesiritide)

Scios - Indication: Acute conjestive Heart Failure - Natrecor is a genetically engineered b-type naturetic peptide. It is as effective as nitroglycerin, the current standard, but may act more quickly and be somewhat easier to administer.

NuvaRing (Etonogestrel with Ethinly Estradil)

Organon - This is the first contraceptive which exerts its antifertility effect locally by a ring inserted into the vagina the 5th day of menstrual period and removed 21 days later This formulation avoids the problem of compliance which for some women, leads to an unwanted pregnancy. The use of lower doses of progestin and estrogen suggests that the incidence of side effects can be expected to be lower than either oral or injection birth control drugs. The most frequent reported side effects in 5-14% of women are: increased vaginal discharge, headache, respiratory tract infections, weight changes, and nausea.

PEG-Intron (Peginterfern Alfa-2b)

Schering - this inectable drug is indicated for the treatment of chronic hepatitis C in patients not previously treated with interferon alpha. This product is different from the one found in the combination with ribivarin (Rebetron) which is not the PEG for. PEG-Intron is approximately twice as effective (24% vs 12%) in normalizing liver function and serum virus content when compared to regular Intron.

Protopic (Tacrolimus)

Fujisawa - this newly approved ointment for atopic dermititis is a significant improvement over the use of topical steroids, particularly in infants and children. In three separate studies 30-35% of patients experienced 90% or better improvement in their skin condition. Greater than 2/3 young children experienced significant improvement.

Reminyl (Galanthamine)

Jannsen - This is a new addition to the drugs used to slow the progression of Alzheimer's Disease. It acts by inhibiting the enzyme acetylcholinesterase. This results in higher brain levels of acetylcholine. It is widely believed that a deficiency of acetylcholine is partially responsible for the symptoms of Alzheimer's disease. Side effects are relatively mild and include: nausea and vomiting (19%), diarrhea (10%), a decrease in weight (9%), and tiredness (6%). This drug will not be available in the USA until May 2001.

Solaraze (Diclofenac)

This topical agent is indicated for the treatment of actinic keratoses, a potential first step in the development of skin cancer. When applied topically, Solaraze produced complete clearing of lesions in 30-40% of patients who applied the gel twice daily for 90 days.

Starlix (Nateglinide)

Novartis - this is an oral drug for the treatment of type 2 diabetes. Starlix is a derivative of phenylalanine and acts by stimulating the release of insulin. It is indicated to reduce the glucose spikes which typically occur after meals. The most common side effects are: upper respiratory infections, flu-like symptoms, dizziness and joint pains.

Valcyt (Valganciclovir)

Syntex - this new drug has been approved for use in the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome.

Yasmin (Ethinyl Estradiol and Drospirenone)

Berlex Labs - this is an interesting addition to the many oral contraceptives currently available in the USA. The fact which makes it interesting is the presence of a new progestational agent, drospirenone. Drospirenone seems to produce less breast tenderness and bloating than other progestins found in oral contraceptives. Because it retains potassium it should be used with caution in women with kidney insufficiency or those taking potassium sparing diuretics such as triamterene and spironolactone.