New Drugs and Devices 2006

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Amitiza (Lubiprostone)

Takeda – This drugs indicated for the treatment of chronic idiopathic constipation. The mechanism is unique in that it increases intestinal secretion of chloride ion thus bring water into the intestine and increasing fecal fluidity. Side effects are relatively mild and include nausea (31%), diarrhea (13%), headache (13%), and abdominal pain and distension (7%).

Anthelios SX (Ecamsule, Avobenzone and Octocrylene)

L'Oreal – This newly approved topical sunscreen is unique in that it blocks both UVA and UVB rays, a property unique to this new agent. Side effects are mild and include:acne, dermitis, eczema, and itching.

Atripla (Sustiva® (efavirenz), Viread® (tenofovir DF) and Emtriva® (emtricitabine))

Gilead — Atripla is an anti-HIV medication. It contains two different types of anti-HIV drugs: one non-nucleoside reverse transcriptase inhibitor (NNRTI) and two nucleoside reverse transcriptase inhibitors (NRTIs). Atripla is a combination of three drugs: 600mg of Sustiva® (efavirenz), 300mg of Viread® (tenofovir DF) and 200mg of Emtriva® (emtricitabine). Atripla should be prescribed by a healthcare provider for patients who need all three of these drugs. Many patients have dizziness, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams a few hours after starting treatment with Sustiva, one of the drugs in Atripla. These feeling may be less noticeable if you take Atripla at bedtime. They also tend to go away after you've taken the medicine for a few weeks.

Azilect (Rasagiline)

Teva — This new oral agent for Parkinsons Disease appears to slow the progression of the disease. In addition, the improvement appears to be sustained with improvement persisting for 6 years in some studies. Side effects are mild and include: headache (14%, joint pains (7%, gastric upset (7%), and depression (5%).

Brovana (Arformoterol)

Sepracor —This new drug which is given by inhalation has been approved for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). This is the first long-acting beta-2 agonist which acts by dilating the pulmonary alveoli thus alleviating the symptoms of COPD. The major advantage of this preparation is that it is given twice daily while the standard bronchodilator given for COPD, albuterol, is taken every 4-6 hours.
This medication will not be available until mid-2007.

Cesamet (Nabilone)

Valeant — Cesamet is an synthetic cannabinoid available as a oral tablet with antinauseant properties . It is approved for use in patients with nausea and vomiting associated with cancer chemotherapy. The most common side effects include: drowsiness (58%),vertigo (56%) , dry mouth (29%), and a psychological “high” (16%). Adverse psychiatric reactions can persist for up to 48 hr. following cessation of treatment.

Chantix (Varenicline)

Pfizer – This new drug is approved as an aid in smoking cessation programs. It acts by blocking a specific nicotinic acetylcholine receptors (alpha4,beta2).In clinical studies of continuous abstinence for weeks 9-12, 45% of Chantix patients continued not to smoke and in another longer study, weeks 9-52, 20% remained smoke-free. Side effects for this drug which is taken by mouth are mild and mainly consist of nausea(23%), insomnia (18%), headache (17%), and abnormal dreams (11%).

Dacogen (Decitamine)

MGI Pharma – This newly approved drug is indicated for the treatment of mylodysplastic syndrome. The complete and partial response rate was 17%. Side effects are serious and include neutropenia, thrombocytopenia, and anemia.

Dermatop (Prednicarbate)

Dermik — this new preparation is indicated for the treatment of the symptoms of eczema. Side effects are rare (less than 1% of patients) but include swelling, hives, and rash.

Elaprase (Idursulfase)

Shire – This is an important addition to drugs used to treat rare metabolic disorders. In this case Elaprase,which is given by infusion, is used to treat Hunter Syndrome also known as Mucopolysaccharidosis II (MPS II). It replaces the enzyme iduronate-2-sulfatase, which is deficient in those patients with Hunter disease and significantly improved both walking performance and pulmonary function. Side effects are mild.

Emsam (Selegiline)

Somerset – This is a new dose form of an already approved drug used to treat Parkinson’s Disease. Emsam patches are indicated for the treatment of major depression. It is in the class of MAO inhibitors that have been associated with dietary restrictions (cheeses) to avoid hypertensive reactions, a common side effect of MAO inhibitors. The systemic dose absorbed by this product is much lower than the oral dose and the side effects of the other MAO inhibitors are avoided.

Eraxis (Anidulafungin)

Pfizer – This new injectable antifungal agent is indicated for the treatment of fungal infections due to Candida. Specifically, it is indicated for the treatment of Systemic candidiasis, peritonitis and esophageal candidiasis. Side effects include; diarrhea, reduced potassium levels, and an increase in liver enzyme values.

Exuba (Insulin Human - rDNA Origin)

Pfizer – This is the first insulin product that is given by inhalation instead of the commonly used subcutaneous (injection) route. It is indicated for the prevention of the post-meal (postprandial) increase in blood glucose. It is not indicated for Maintenance of normal blood glucose levels throughout the day which will still require injected insulin products. It has been approved bothe for Type 1 (Insulin-dependent) and Type 2 (Maturity onset) diabetes. The only side effect which is different from that of regular insulin is a small decrease in markers of pulmonary function. And can produce mild coughing. Exubra should not be used in patients who currently smoke or who have stopped smoking less than 6 months prior to treatment.

Gardasil (Quadrivalent human papillomavirus (HPV) types6,11,16,18 recombinant vaccine)

Merck – This new vaccine is a significant advance in preventing the eventual development of cervical cancer due to the HPV virus. Clinical studies have shown that Gardisil is 100% effective in preventing the onset of high-grade pre-cancer of the cervix. Side effects were minimal and limited to irritation at the injection site.

Januvia (Sitagliptin)

Merck – This newly approved drug is indicated as either monotherapy or it can be combined with other oral diabetes medication for the control of blood glucose levels in patients with Type II diabetes. It acts by a new mechanism, namely the enhancement of the incretin system, which helps to regulate blood glucose by affecting the beta and alpgha cells in the pancreas. Side effects were similar to placebo. The pharmacology allows this drug to be taken once daily.

Juvederm (Cross-linked Hyaluronic Acid)

Allergan – This newly approved preparation is used as a dermal filler which when injected into a specific location in the face will remove facial wrinkles. It is particularly popular in temporarily treating the deep fold lines which run from the bottom of the nose to the outer corners of the mouth.

Lucentis (Ranibizumab)

Genentech – This is the second drug of its class and is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). It acts by binding and inhibiting VEGF-A, a protein believed to play a significant role in the formation of new blood vessels, In AMD, the proliferation of blood vessels in the retina results in the leakage of blood into the retinal space and subsequent damage to the macula, the portion of the eye responsible for fine, detailed central vision. in 95% of patients the AMD stopped progressing and in 40% there was a significant improvement in visual acuity. Note: This drug is restricted in the United States and not available for export.

Myozyme (Alglucosidase Alfa)

Genzyme – This new drug represents a significant advance in the treatment of this rare hereditary disorder which heretofore has been 100% fatal in infants with Pompe disease. Pompe disease is an inherited disorder of glycogen metabolism caused by an absence or marked deficiency of GAA. This new drug acts by replacing the deficiency of GAA thus slowing or reversing the progression of the symptoms of the disease. Serious side effects include the possibility of severe allergic reactions including anaphylactoid reactions, and infusion reactions affecting both the cardiovascular and respiratory systems. Other side effects include: fever (97%), cough (46%), pneumonia (46%), diarrhea (62%), vomiting (49%), and rash (54%).

Noxifil (Posaconazole)

Schering – This newly approved antifungal drug is indicated in the treatment of fungal infections due to Aspergillus and Candida which are resistant to other available antifungal drugs. These infections occur most frequently in patients with compromised immune systems such as occur after bone marrow transplantats and those whose immune systems are impaired. This drug is usually given prophylactically (before infections occur) and is either better than or similar to other antifungal drugs given for the same purpose. Common side effects include nausea, vomiting, diarrhea, rash, a lowered serum potassium level and abnormalities in liver function.

Opana (Oxymorphone)

Endo – A new oral extended-release opioid analgesic option for patients, Opana(R) ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time and is not intended to be used on an as-needed basis. This is the first time oxymorphone will be available in an oral, extended-release formulation. Opana(R) ER will be available in 5mg, 10mg, 20mg and 40mg tablets. Opana(R) (the immediate release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate and will be available in 5mg and 10mg tablets.

Prezista (Darunavir)

Tiborec – This is a new protease inhibitor indicated for the treatment of HIV infections. It is indicated for HIV strains resistant to the more commonly used protease inhibitors such as Crixivan. Prezista appears to be very useful against both wild-type (wt) and multi-drug resistant HIV. It should be given in combination with ritonavir and also with Fuzeon. The most common side effects are: rashes which were in most part self-limiting,diarrhea, nausea, and headache. Note: This is a very expensive drug at a cost >$25 USD/day

Ranexa (Ranolazine)

CV Therapeutics – This new oral agent is a valuable addition to the drugs available for the treatment of chronic angina. It acts to improve the efficiency of oxygen utilization by heart muscle. Thus, the heart can generate the same amount of energy with better oxygen utilization. It differs in pharmacology from the other drugs currently available to treat angina. Side effects are rare and consist of dizziness and nausea. Rarely, a drop in blood pressure upon standing (postural hypotension) may occur.

Rotateq (Rotavirus Vaccine)

Merck – Rotavirus infections affect 2.7 million children in the USA each year and results in the deaths of approximately 500,000 children worldwide. The major symptom is severe gastrointestinal upset with diarrhea. The vaccine protected virtually all children from severe infections and significantly reduced the number of children who developed the infection. Vaccination requires 3 doses of Rotateq given by mouth to infants shortly after birth and at one month intervals until finished.

Seasonique (Levonorgestrel/Ethinyl Estradiol)

Barr – Under the Seasonique extended-cycle regimen, women take active tablets of 0.15 mg levonorgestrel/0.03 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.

Sprycel (Dasatinib)

Bristol-Myers – Sprycel is an oral inhibitor of multiple tyrosine kinases, for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy, including Gleevec® (imatinib mesylate). IMPORTANT SAFETY INFORMATION – Sprycel is not recommended for use in pregnant women or those contemplating pregnancy. Dasatinib may cause fetal harm. Sexually active male/female patients taking Sprycel should use adequate contraception. The most frequently reported adverse events included fluid retention events, such as pleural effusion, gastrointestinal events including diarrhea, nausea, abdominal pain and vomiting and bleeding events.

Sutent (Sunitinib)

Pfizer – This new agent which is taken by mouth has been approved for the treatment of Gleevec-resistant gastrointestinal stromal tumors (GIST) and meetastatic renal cell carcinoma (mRCC). This drug is a significant addition to the drugs available for the treatment of GIST where it significantly prolonged the median time to disease progression as well as extending survival to almost 20 months. When used to treat mRCC 68% of treated patients responded either with tumor regression (40%) or tumor stabilization (28%). Sutent acts by targeting tyrosine kinase receptors which when blocked deprives the cancer cells of Blood and nutrients needed for growth while simultaneously producing cancer cell death. Side effects are mild to moderate and consist of fatigue, low white blood cell counts, and gastrointestinal upset.

Truvada (Emtricitabine and Tenofovir)

Gilead – This newly approved combination medication is indicated for the treatment of newly diagnosed HIV infections. Its advantage over other drugs used to treat HIV infections is that it can be given once daily thus reducing the need for multiple dosing and potentially improving patient compliance with the multiple drug regimen. Significant side effects include lactic acidosis and hepatomegly with steatosis.

Tysabri (Natalizumab)

Biogen-Idec – This drug originally approved for the treatment of relapsing multiple sclerosis was pulled from the market in 2005. This was due to the occurrence of a rare but fatal side effect called multifocal leukencephalopathy (PML). Since then, there has been additional followup of patients who have received this drug and the US food and Drug Administration has determined the benefit in MS is such that they will allow Tysabri to be available again on a restricted basis. Tysabri reduces the risk of disease progression and a reduction of the brain lesion commonly found in patients with MS.

Vaprisol (Conivaptan)

Astellas Pharma – This newly approved drug is indicated for the treatment of euvolemic hyponatremia. This is a condition characterized by a fall in blood sodium levels significantly below the normal range. Treatment with Vaprisol results in an improvement in sodium levels during the first 24 hrs. after start of therapy. It acts as an antagonist of arginine vasopressin. Adverse reactions are mild to moderate and include: hypokalemia, headache, thirst and vomiting.

Vectibix (Panitumumab)

Amgen — Vectibix has been approved for the treatment of colorectal cancer that has metastasized to other parts of the body. It is a monoclonal antibody that binds to epidermal growth factor receptor thus slowing down tumor growth and in some cases reduced tumor size. Patients given Vectibix had a longer time to disease progression (96 vs 60 days on standard therapy) with 8% of patients having a reduction in tumor size of 50% or greater. Serious adverse effects include: pulmonary fibrosis, severe skin rashes, and abdominal pain. Less severe but more common side effects include: fatigue, nausea, and diarrhea.

Vivitrol (Naltrexone Extended Release Suspension)

Cephalon – This newly approved dose form of naltraxone is an injection given to assist alcohol-dependent patients who are able to abstain from drinking in an outpatient setting. It is given once monthly and acts by blocking a set of opioid receptors in the brain called the mu receptors. Like naltrexone, this new dose form may produce liver damage and liver functions tests should be performed routinely.

Zolinza (Vorinostat)

Merck — Zolinza has been recently approved for the treatment of cutanous t-cell lymphoma (CTCL). Clinical studies have shown improvement in skin lesions in 30% of treated patients. The improvement lasted for an average of 168 days. Zolinza is given by mouth with meals. Serious side effects include; dehydration, blood clots in the lungs, and anemia. Less serious and more common side effects include: diarrhea, nausea, anorexia, chills, fatigue, and taste disorders.

Zostavax (Zoster)

Vaccine Live (Oka/Merck)
Merck – This is the first vaccine available for the prevention of shingles,a painful disease characterized by a blistering rash and severe pain localized to specific nerves. Both the rash and pain can persist for months or even years. This disease increases in frequency with age and prevalence increases in those over 60 who had chicken pox when they were children or young adults. Approximately 50% of all cases of shingles occur in persons over 60 years of age. Zostavax significantly reduced the risk of developing shingles compared with placebo by 51 percent (315 cases [5.4 cases per 1,000 person-years] vs. 642 cases [11.1 cases per 1,000 person-years], respectively; p<0.001) in the SPS. Efficacy of ZOSTAVAX for the prevention of shingles was highest for those 60 to 69 years of age and declined with increasing age.