New Drugs and Devices 2004

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Acetadote (Acetylcysteine)

Cumberland pharmaceuticals — this new product in an injection indicated for the prevention of the liver damage resulting from overdoses (accidental or purposeful) of the common analgesic acetaminophen (Tylenol) or paracetamol (outside of USA). It is given by injection. It needs to be given by 8-10 hours after the injection. Delay beyond that time substantially reduces the effectiveness.

Alimta (Pemetrexed)

Lilly — this is the first agent with specific approval for the treatment of mesothelioma. It acts by interfering with the development of folate-dependent enzymes. Those enzymes are required for the biosynthesis of thymidine and purine nucleotides, essential factors for malignant cell growth. Results of 5 trials showed an increase in survival from 7 months to 13 months for patients receiving Alimta plus cisplatinum. The overall incidence of side effects was 5% with bone marrow depression, nausea and mouth sores reported.

Amphadase (Hyaluronidase)

Amphastar — Amphadase is a drug injected under the skin to help increase the absorption and dispersion of another drug. Hyaluronidase increases tissue permeability and promotes the spread or dispersion of other drugs. Amphadase is also approved for use as an adjunct (in addition to) to rehydrating agents and for use with certain imaging agents. Amphadase is a cow sourced (bovine) form of hyaluronidase.

Apidra (Insulin Glulisine)

Aventis — Apidra is a recombinant insulin (not from animal sourcss) which differs from other forms of insulin in that it has a very rapid onset of action. When used as a meal time insulin it is given within 15 minutes after completion of a meal. Adequate glucose control requires the use of another longer acting insulin in conjunction with Apidara.

Apokyn (Apomorphine)

Bertek — Apokyn in injectable form has been approved for the treatment of episodes of hypomobility frequently seen in Parkinson's disease. During these "off" periods patients are unable to rise from a chair,to speak or walk. Apokyn can be expected to help appproximately 10% of those patients. Apokyn must be taken with an effective antiemetic such as ondansetron as a major side effect without an antiemetic is nausea and vomiting. Other side effects include: low blood pressure, hallucinations, and excessive sleepiness.

Avastin (Bevacizumab)

Genentech — This is the first anti-cancer drug in the class of anti-angiogenesis agents and therefore represents a significant forward movement in the treatment of malignancies in general. Avastin acts by inhibiting the development of the blood supply to newly developing malignant tissue. Thus its value appears to be in inibiting the growth of highly vascular tumors such as adenocarcinoma of the colon and rectum. In one clinical study, patients who received standard therapy plus Avastin survived for a median of 20.3 months compared with another group receiving standard therapy alone of 15.6 months. A unique side effect is that of hypertension treatable with existing antihypertensive drugs and rarely, perforation of the bowel.

Campral (Acamprosate)

Forest Labs — Campral is indicated for the treatment of chronic alcoholism. The mechanism of action is unknown. It does not involve any effects on the metabolism of alcohol such as disulfiram. Controlled studies showed its effectiveness in patients who had undergone alcohol dependence Therapy. It was superior to placebo in maintaining abstinance. It was not effective in alcoholics with multiple drug abuse problems who did not undergo detoxification. The major side effect is diarrhea.

Clolar (Clofarabine)

ILEX — Clolar, which is given intravenously, has been approved for the treatment of acute lymphoblastic leukemia in patients 1 to 21 years of age. It is indicated in those whose leukemia has either become refractory to existing therapy or whose disease has relapsed following an initial response to other therapeutic regimens. Of 49 patients, 15 (30%) achieved either a complete or partial response. Side effects are significant and include but are not limited to: nausea, vomiting, bone marrow depression, and kidney damage.

Cymbalta (Duloxitine)

Lilly — Cymbalta is indicated for the treatment of major depression in adults. It acts by inhibiting the reuptake of both norepinephrine and serotonin, a mechanism different from other antidepressents. Side effects include: nausea, dry mouth, constipation, decreased appetite, fatigue, and increased sweating. Although clearly better than placebo in controlled studies there are no data comparing Cymbalta to other currently available antidepressants.

Enablex (Darifenacin)

Pfizer/Novartis — Enablex is a selective M3-antagonist for overactive bladder. Due to muscarinic receptor selectivity, Enablex may have fewer adverse effects as compared with other drugs. However, constipation, dry mouth, headache, nausea, or urinary tract infection may still occur. Enablex is given once a day and is not recommended for use by patients with severe liver impairment.

Epzicom (Abacavir and Lamuvidine)

GlaxoSmithKline — This drug contains both Ziagen and Epivir, two currently approved drugs for the treatment of HIV-AIDS infections. The two drugs are reverse transcriptase inhibitors. This combination must be used together with other drugs which act on the HIV virus by a different mechanisms. As the combination may be given once a day this combination may improve patient compliance.

Erbitux (Cetuximab)

Bristol-Myers — this long awaited drug is one of the first to target the epidermal growth receptor (EGFR). By blocking the EGFR, malignant cell growth is slowed and disease progression is retarded. In combination with other drugs used to treat colorectal cancer tumor shrinkage was observed in 23% of patients with tumor growth delayed 4.1 months. Significant side effects include: difficulty in breathing and low blood pressure. More commonly seen are: acne-like rash, dry skin, weakness, fever, constipation and abdominal pain.

Fosrenol (Lanthanum Carbonate)

Shire — Fosrenol is a chewable tablet to treat hyperphosphatemia (too much phosphate in the blood). Fosrenol does not contain calcium or aluminum like other drugs for the condition. Fosrenol appears to be well tolerated. In addition to taking Fosrenol, patients need to adhere to the diet prescribed by their physician.

Istalol (Timolol)

Ista — This new formulation of the widely prescribed drug ophthalmic timolol, is used to treat ocular hypertension and wide-angle glaucoma. It has an advantage over other timolol products in that it can be given once daily. However, because timolol for ophthalmic use is available generically, Istalol will likely be substantially more expensive.

Kepivance (Palifermin)

Amgen — severe mucositis (mouth and throat) is a common, extremely uncomfortable complication of chemotherapy and radiation therapy for cancer. This intravenous preparation stimulates cells in the oro-pharangyeal region to regrow more quickly after initial destruction by the therapy. Clinical trial results are impressive with a reduction in Grade 4 severity from 62% to 20% and a significant improvement in symptoms in 8 days compared to 14 days without Palifermin. Less analgesia for oral and pharangyeal pain was required in the Palifermin group compared with placebo. Side effects include; edema (205), rash (62%), itching (35%), and fever (39%). A temporary increase in blood pressure may also occur.

Ketek (Telithromycin)

Aventis — this antibiotic is indicated for the treatment of mild to moderate acute exacerbations of sinus infections or chronic bronchitis. It is the first in a new class of antibiotics called ketolides. This class acts by interfering with bacterial protein synthesis. side effects are mild and include diarrhea, nausea and headaches.

Lunesta (Eszopiclone)

Supracor — Lunesta has been approved for the treatment of insomnia. It is available as an oral dose. It is not a benzodiazepine thus neither addiction or tolerance. It has an advantage over most other sedatives in that not only is its onsent very rapid but also it appears to maintain its sleep-inducing effect for 6-8 hours. Side effects include: unpleasant taste (25%), headache (21%), dry mouth (6%), and an increased incidence of respiratory tract infections (7%).

Macugen (Pegaptanib Sosium)

Eyetech (Pfizer)s — Macugen is used for the treatment of neovascular (wet) age-related macular degeneration (AMD). It acts by inhibiting blood vessel growth and proliferation in the macular region of the eye. Macugen appears to slow vision loss associated with AMD. Macugen does not restore vision if the photoreceptors in the eye are already damaged and degenerated. Macugen is injected into the eye every 6 weeks by an ophthalmologist.

Menostar (Estradiol)

Berlex — Menostar is a patch which is applied weekly to the lower abdomen. It is indicated for the prevention of osteoporosis in post-menopausal women. It does not require a concomitant dose of a progesten. The adverse effects are similar to placebo patch.

Myfortic (Mycophenolic Acid)

Novartis — this new oral enteric-coated drug is indicated for the prevention of rejection following organ transplantation. it is the same chemical entity as Cellcept. This alternate dose form may offer a lower incidence of gastrointestinal side effects thus reducing the need for a dose adjustment. Patients who required a dose adjustment were eight times more likely to experience acute organ rejection than those not requiring a dose adjustment.

Omacor (Omega-3-fatty Acids)

Ross/Abbott — Omacor is a new preparation available as a Capsule for oral administration. It has been approved for secondary prevention for patients surviving a myocardial infarction where it significantly reduced all cause mortality and sudden death. It is also indicated for the management of excess levels of triglycerides in the blood, a consistent risk factor for cardiovascular diseases.

Orthovisc (High Molecular Weight Hyaluronan)

Ortho — Orthovisc, an injectable form of hyaluronic acid, is indicated for the treatment of moderate to severe osteoarthritis of the knee. It is injected intrasynovially and in doing so increases the distance between the synovium and the joint thus reducing contact, inflammation and pain.

Palladone (Hydromorphone)

Purdue — Palladone is an oral capsule containing hydromorphone in a sustained release form. It is indicated for the treatment of persistant moderate to severe pain requiring around-the-clock analgesia in patients already taking opiates. Thus, it is similar in pharmacology to OxyContin but is a more potent analgesia drug. Side effects are similar to other opiates and consist of drowsiness, constipation, dry mouth, and weakness.

Pentetates, Calcium and Zinc

Hameln— Pentetate calcium trisodium (CA-DTPA) and pentetate zinc trisodium (ZN-DTPA) injections are the first drugs approved for use in treating exposures to radiation, specifically, plutonium, americium, and curium. If exposure is only through the air, ZN-DTPA is recommended. If both products are available and if exposure occurred within 24 hrs, CA-DPTA should be given first followed by ZN-DTPA. Side effects are mild with an occasional patient complaining of difficulty in breathing.

Prialt (Ziconotide)

Elan — Prialt is a new drug which is administered intrathecally approved for use in the treatment of severe pain not responsive to other pain treating drugs. It acts as a N-type calcium channel blocking agent, a unique mechanism among analgesic drugs. Side effects are relatively mild and include: dizziness, nausea, weakness, and drowsiness.

Sanctura (Trospium)

Odyssey — Santura is an oral tablet approved for use in the treatment of overactive bladder with symptoms of urinary incontinence and urinary frequency. It acts by inhibiting the cholinergic impulses to the bladder thus allowing for better retention of urine and less urge to urinate when the bladder is not full. Side effects due to its anticholinergic action are: dry mouth (20%), constipation (10%), headache (4%) and fatigue (2%).

Sensipar (Cincalcet)

Amgen — this oral effect drug is approved for the treatment of hypercalcemia secondary to a benign growth of the parathyroid glands. It is one of a class of calcimimetics which activate calcium receptors and decrease secretion of parathyroid hormone. In one group of hyperparathyroid patients, 88% had calcium blood levels return to normal. Side effects were similar to placebo.

Spiriva (Tirotropium)

Boehringer and Pfizer — Spiriva is a significant new and valuable addition to a small list of drugs used to reduce the symptoms of chronic obstructive pulmonary disease (COPD) which is accompaied by bronchospasm. It mechanism of action is simiar to ipratropium, an anticholinergic which reverses airway constriction. Spiriva is a powder given by inhalation. It is given once a day using a powder inhaler. Clinical studies showed a significant improvement in respiratory symptoms compared to ipratropium with its 24 hour duration a significant advantage. Side effects are mild and include dry mouth (usually disapearing after treatment), and infrequently, increased heart rate and constipation. Use with caustion in patients with glaucoma and prostatic hyperplasia as Spiriva use may worsen those conditions.

Tarceva (Erlotinib)

Genentech — Tarceva is an oral tablet indicated for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). It acts by inhibiting tyrosine kinase located in Epidermal Growth Factor receptors. This inhibition results in a less rapid proliferation of the malignant cells of NSCLC, an epidermal cell cancer. Compared with placebo, positive effects on median survivial and percent alive after 12 months were modest but statistically significant. Side effects were the same as seen with the placebo however, there have been occasional reports of serious Interstitial Lung Disease.

Tindamax (Tinidazole)

Presutti — Tinadmax is indicated for the treatment of infections due to T. vaganilis, G. Lambia, and E. histolytica. Although its mechanism of action is similar to that of metronidazole it does have the advantage of requiring a shorter duration of therapy for effective treatment. It may also have a somewhat lower incidence of nausea and vomiting than metronidazole. Alcohol should be avoided while on Tindamax therapy. Because of its effect on liver drug metabolism, there are a number of potential drug interactions including: warfarin, lithium, phenytoin, cyclosporin and fluorouracil.

Truvada (Emtricitabine and Tenofovir)

Gilead — This newly approved drug is a combination of two currently available drugs for HIV, Emtriva and Viread. Both of the two drugs are reverse transcriptase inhibitors. Truvada is given once a day and must be used in combination with other drugs with different mechanisms of action also active against the HIV virus. As the combination may be given once a day this combination may improve patient compliance.

Tysabri (Natalizumab)

Biogen — Tysabri also known as Antegren is a newly approved injectable medication indicated for the treatment of relapsing-remitting multiple sclerosis. It acts by binding to the Alpha-4 site located on the surface of inflammatory cells. This prevents or slows the migration of these cells to areas of inflammation surrounding the nerves affected in MS thus reducing inflammation and preventing further damage. This is a significant addition to this frustrating disease. Side effects include: headache, fatigue, and nasopharyngitis.

Vantus (Histrelin)

Valera — This drug comes in the form of an implant which releases the active drug continuously over 12 months. It acts as an agonist (stimulant) of leutinizing hormone-releasing hormone (LNRH). This results in virtual elimination of any residual testosterone in the blood (most metastatic prostate cancers are testosterone-dependant). Side effects include: hot flashes (65%), weakness (10%), testicular atrophy (5%) and renal impairment (5%).

Ventavis (Lloprost)

CoTherix — This is an important addition to the treatment of pulmonary artery hypertension, a potentially lethal condition characterized by high blood pressure in the pulmonary arteries. Ventavis is administered by inhalation, a significant advantage over the only other available product available in the United States for this condition which until now required continuous intravenous infusion. It acts by producing arteriolar vasodilation and because of the inhalation route of administration, its vasodilation effects mainly occur in the lung. Side effects include: facial flushing, increased cough, hypotension, headaches, nausea, and spasm of jaw muscles.

VESIcare (Solifenacin Succinate)

Yamanouchi Pharma — VESIcare is a selective M3-antagonist for overactive bladder. Due to muscarinic receptor selectivity, VESIcare may have fewer adverse effects as compared with other drugs. However, constipation, dry mouth, headache, nausea, or urinary tract infection may still occur. VESIcare is given once a day and appears to be very effective for reducing urinary urgency and accidents.

Vidaza (Azacytidine)

Pharmion — This newly approved drug is used to treat myelodysplactic syndromes (MDS) which are characterized by the production of abnormally functioning immature blood cells. The incidence of this disease increases with age. It appears to have two different mechanisms of action. The first is to demethylate abnormal DNA in hematopoetic cells in the bone marrow which restores normal function to those cells. The second is to produce the death of rapidly dividing abnormal cells responsible for the symptoms of MDS. Although the response rates were low at 12-16% those data compare favorably with the non-treated groups who had no response to other standard therapy. The most significant side effect was bone marrow depression with gastrointestinal (nausea, vomiting, diarrhea) and fatigue also being commonly reported.

Vitrase (Hyaluronidase)

Ista — Vitrase is an injectable drug approved as an adjunct to (in combination with) other injected drugs to increase their absorption and dispersion. Vitrase has been used most commonly in combination with local anesthetics in the setting of ophthalmic (eye) surgery. Hyaluronidase increases tissue permeability and promotes the spread or dispersion of other drugs, for example, speeding the onset of action for an anesthetic. Vitrase is also approved for use as an adjunct to rehydrating agents, and for use with certain imaging agents. Vitrase is a sheep sourced (ovine) form of hyaluronidase.

Vytorin (Simvastatin and Ezetimibe)

Merck — this newly approved drug combines two different drugs each with a different mechanism of lowering blood cholesterol. The first is simvastatin (Zocor) which acts to prevent the synthesis of cholesterol and ezetimibe which reduces the absorption of cholesterol from the gastrointestinal tract.

Xifaxan (Rifaximin)

Salix — This newly approved oral medication is approved for the treatment of travelers diarrhea (TD) due to E. coli bacteria. It is minimally absorbed into the body thus exerts its pharmacology in the gastrointestinal tract. Thus, systemic side effects are minimal and are limited to flatulance and abdominal pain. Currently it is only approved for the treatment of TD however the manufacturer has applied for approval as a preventive (taken prior to anticipated exposure).