New Drugs and Devices 2007

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Altabax for impetigo

Altabax (Retpamulin)-Glaxo-This topical preparation has been approved for the treatment of children with impetigo due to methicillin-sensitive S. aureus and S. pygogenes. It is applied to the lesions twice daily for 5 days. A controlled study resulted in successful reslution of the lesions in 85% of children treated with Altabax. The most common side effect was local irritation.

Azasite for bacterial conjunctivitis

Azasite (Azithromycin)-Inspire-this is the first ophthalmic preparation of azrithromycin n the USA. It is indicated for the treatment of bacterial conjunctivitis (pink eye). Although no more effective than tobramycin and dramatically more expensive its dose schedule of every 12 hours increases the likelihood of patient compliance.

Bysystolic for hypertension

Bysystolic (Nebivolol)-Mylan-this new antihypertensive drug lowers blood pressure by reducing peripheral vascular resistance while increasing stroke volume of the heart thus preserving cardiac output. Side effects are generally mild and consist of headache, dizziness, and parasthesias.

Fentora for severe cancer pain

Fentora (Fentanyl)-Cephalon-this is a oral new dose form of fentanyl which prior to this time has been available only as patches and as an injection. It is a buccal tablet (absorbed through the cheek) and is designed to dissolve in the mouth, not to be swallowed, It is indicated for the treatment of breakthrough pain in cancer patients already receiving or tolerant to opioid therapy. Side effects are similar to other opioids and consist mainly of central nervous system depression.

Flector for acute inflammation

Flector (Diclofenac Epolamine)-Instituto Biochimico-this topical patch is a new dose form of the commonly used anti-inflammatory drug diclofenac. Its advantage over the oral dose forms is a very rapid absorption with anti-inflammatory effects occurring 15 min. after application.

Invega

Invega (Paliperidone)-Janssen-this newly approved drug is indicated for the treatment of schizophreia. Initial trials evaluated its effectiveness for only 6 weeks so therapy beyond that time is considered investigational. Invega is the active metabolite of resperidone and shares the parent drug’s pharmacology. The mechanism of action is proposed to be mediated through a combination of central dopamine and serotonin receptor antagonism. Invega may produce an increase in QT interval and should not be used with other drugs which also product a similar EKG effect such as quinidine and amiodarone. There is an increase in mortality in elderly patients with dementia-related psychosis.

Isentress for resistant HIV virus infections

Isentress (Raltegravir)-Merck-This new drug is indicated for the treatment of HIV-positive patients who virus has become resistant to the standard retroviral therapy. Isentress acts by inhibiting integrase, an intracellular enzyme which allows the HIV virus DNA to integrate with the normal cell DNA to produce more virus. Isentress is not indicated for children with HIV-infeactions. Side effects include: diarrhea, nausea, and headache. It may also increase blood levels of creatine kinase, an enzyme found primarily in muscle. Thus it should be used with caution in patients with wasting muscle diseases.

Ixempra for advanced breast cancer

Ixempra (Ixabepilone)-Bristol-Myers-this new drug has been approved for meetastatic or locally advanced cancer of the breast whose tumors are resistant or refractory to the first-line therapies for breast cancer. It acts bt preventing the formation of microtubules in the malignant cells thus retarding tumor growth. One clinical study achieved a partial response rate of 12.4%. Another study showed an improvement in progression-free survival of 5.7 months vs. 4.1 months when compared to capecitabine monotherapy. Side effects are common and significant including peripheral neuropathy (65%), fatigue (60%), diarrhea (44%) and mouth ulcers (31%). Over 60% of patients also developed neutropenia with 54% of those moderate to severe.

Kuvan for phenylketonuria

Kuvan (Sapropterin)-Biomarin-this newly approved drug is indicated for the treatment of phenylketonuria (PKU) an inborn error of metabolism. Untreated PKU in infants can lead to mental retardation, small brain size, delayed speech development and other neurological signs. PKU is caused by defective phenylalanine hydrolase (PAH), an enzyme which normally breaks down phenylalanine into non-toxic metabolites. Kuvan increases PAH activity in PKU patients with residual PHA activity. Until Kuvan, PKU was treated solely through dietary measures. This drug, which is given by mouth has mild to moderate side effects. Among those are; headache, diarrhea, abdominal pain, upper respiratory tract infections and throat pain.

Letaris for pulmonary artery hypertension

Letaris (Ambrosentan)-Gilead-this is an important addition to the limited number of drugs approved for use in the treatment of pulmonary artery hypertension (PAH). PAH eventually results in heart failure which symptomatically produces severe tiredness, difficulty in performing any activity which requires an effort. Eventually, the heart failure is so severe as to incapacitate the individual with PAH and result in death. This new agent which is taken by mouth produced a significant improvement in six-minute walk distance. It also significantly delayed the time to clinical worsening of PAH. The most common side effects were peripheral edema, headache, flushing and shortness of breath.
Less frequent but potentially more significant is the occurrence of elevated liver enzymes (ALT and AST). A increase in enzyme levels coupled with clinical symptoms of liver injury indicate that Letaris should be discontinued.

Lybrel for birth control

Lybrel (Levonorgestrel/Ethinyl Estradiol)-Wyeth-this is the first contraceptive medication where the active drug is taken for all 28 days of a normal cycle. Although breakthrough bleeding is common no menstruation occurs.

Omnaris for seasonal rhinitis

Omnaris (Ciclesonide)-Altana Pharma-this is an addition to the group of steroids administered nasally for the prevention and treatment of seasonal rhinitis (hay fever). This steroid can be used either once or twice a day. Side effects are minimal and comparable to placebo.

Noxafil for invasive fungal infections

Noxafil (Posaconazole)-Schering-this drug has been approved for the prophylaxis against Apergillus and Candida infections in patients whose immune systems have been compromised by chemotherapy, bone marrow transplants, or from prolonged depression of white blood cells. It is available as an oral suspension. Patients taking either cyclosporine or tacrolimus will require dose reductions if Noxifil is added to therapy.

Neupro for Parkinson’s disease

Neupro (Rotigotime)-Schwartz Bioscience-Neupro, available as a skin patch, is the first agent approved for Parkinson’s disease which is applied to the skin. Parkinson’s disease is believed to be due in part to a deficiency of dopamine in the brain. Neupro is a acts by stimulating dopaminergic receptors in the brain thus partially overcoming the relative lack of dopamine responsible for the symptoms of Parkinson’s disease. Side effects include irritation at the application site, dizziness, drowsiness, and nausea.

Nuvigil for excessive sleepiness

Nuvigil (Amodafinil)–Cephalon-Nuvigil is a R-enatiomer of modafinil (Provigil) which has already been approved for the treatment of excessive sleepiness (narcolepsy). It differs from Provigil in that it has a much longer duration of action allowing for once a day dosing in the morning. The most significant side effect is a rash which can be severe and include blisters inside the mouth.

Reclast for osteoporosis and Paget’s disease.

Reclast (Zoledronic Acid)-Novartis-this new injectable drug has been recently approved for the prevention of osteoporosis in postmenopausal women and of Paget’s disease in both men and women. Its pharmacology is similar to others in its class (biphosphonates) in inhibiting osteoclast-mediated bone resorption. It differs from the others in having a high affinity to bone mineral. This results in a very long pharmacologic half-life allowing this drug to be given once a year! Side effects include: fever, headache, nausea, muscle pain, bone pain, fever and chills.

Rhophylac for suppression of Rh isoimmunization during preganacy

Rhophylac (Anti-D)-ZLB Behring-this drug is given in pregnancy to prevent Rh isoimmunization in non-sensitized Rho(D)-negative women. It is also indicated for Rh prophylaxis in cases of obstetric complications or invasive procedures during pregnancy. It is also indicated to raise platelet counts in patients with chronic immune thrombocytopenic purpura.

Selzentry for HIV infections

Selzentry (Maraviroc)-Pfizer-This new drug is the first of the class known as known as CCR5 co-receptor atagonists. It acts by blocking the CCR5 receptor. Blockade of this receptor prevents the HIV virus from entering the white blood cells, the target of the HIV virus. Selzentry will be valuable in patients with HIV who have become resistant to other retroviral drugs. The mst common side effects include:cough,fever,upper respiratory tract infections, rash, abdominal pain and dizziness. More unusual but potentially more severe side effects include liver toxicity and the possibility of heart attacks.

Soliris for paroxysmal nocturnal hemoglobinuria (PNH)

Solaris (Eculizumab)-Alexion-this is the first drug approved for the treatment of PNH. PNH results from the breakdown of red blood cells which have developed abnormally. Symptoms of this condition include anemia requiring frequent transfusions, pain, fatigue, and debilitating weakness. Solaris inhibits a component of the system responsible for breaking down the red blood cells.
Solaris administration resulted in stabilization of blood hemoglobin concentrations and a significantly reduced need for blood transfusions. The potential for a serious meningococcal infection is a significant side effect. All patients requiring Solaris must be vaccinated against meningococcal infections.

Somatuline for acromegaly

Somatuline Depot (Lanreotide)-Beaufour Ipsen/Tercica-Somatuline is indicated for the long-term treatment of acromegly, a disease characterized by the excess secretion of growth hormone (HGH). This new drug acts by lowering levels of growth hormone and insulin-like growth factor. Excess blood levels of those two biochemicals results in enlargement of hands, feet, facial bones and internal organs. Somatuline is given by subcutaneous injection every four weeks and is indicated for patients who have not responded well to surgery or radiotherapy.

Supprelin for central precocious puberty

Supprelin (Histrelin)-Indevus-Administered once a year by a subcutaneous implant has been approved for the treatment of central precocious puberty (CPP), a condition more common in young girls than boys. It is a GnRH agonist which causes the suppression of gonadal hormones. If CPP is left untreated it limits the child from attaining full adult height which results in short stature.

Tasigna for Ph+ chronic mylogenous leukemia

Tasigna (Imatinib)-Novartis -this new drug has been approved for Philadelphia chromsome + patients with chronic mylogenous leukemia. It is indicated in those cases where adults have become resistant or intolerant to at least one prior therapy including imatinib (Gleevec). It acts by inhibiting the action of tyrosine kinase, a key intracellular enzyme needed for growth.
It appears to bind more strongly to the tyrosine-kinase binding site than Gleevec, achieve higher intracellular concentrations, and exhibits minimal cross-resistance with Gleevec. In clinical trials 74% of patients in the chronic phase achieved a complete hematologic response. Side effects include: rash, pruritus, nausea, headache, and fatigue. Tasigna was associated with a low incidence of AEs related to fluid retention

Tekturna for high blood pressure

Tekturna (Aliskiren)-Novartis-This is the first of a new class of drugs useful for the treatment of hypertension. Tekturna is the first direct renin inhibitor. Inhibition of renin production is a common mechanism to reduce blood pressure. Blood pressure reduction is additive when other commonly used antihypertensive drugs are added. Side effects are mild and similar to placebo. Tekturna is given once daily.

Totect for anthracycline extravasation

Totect (Dexrazoxane)-Topotarget- this drug is indicated in the treatment of anthracycline-induced extravasation. This occurs if during the administration of a drug such as adriamycin,there is leakage of the drug around the administration site. Should this occur, there is the potential for extreme irritation, pain, and ulceration around the injection site. The mechanism may be to inhibit topoisomerase II which then inactivates the anthracycline chemotherapy agent. Side effects include: nausea, pyrexia, and vomiting. Hematologic monitoring is also recommended.

Torisel for renal cell cancer

Torisel (Temsirolimus)-Wyeth-Torisel is the third drug recently approved for the treatment of renal cell carcinoma. In a controlled study, patients receiving Torisel and interferon showed a median survival of 10.9 months compared to 7.3 months for patients treated with interferon alone. Lack of disease progression improved from 3.1 months to 5.5 months. There was no change in overall survival. Side effects occurred in 30% of patients and included rash, fatigue ,mouth sores, nausea, and loss of appetite.

Tykerb for breast cancer

Tykerb (Lapatinib)-Glaxo-Tykerb is a significant new addition to the current list of drugs active against breast cancer. Tykerb in combination with Xeloda is indicated in women with advanced metastatic disease whose tumors overexpress HER2. Importantly, it is given by mouth and does not require visits to a chemotherapy center to be administered. The response rate measured by a longer time to disease progression is between 24% and 32% with time to disease progression increasing to a mean of 25.5 weeks compared to 18.6 weeks with Xeloda alone.
Side effects when given with Xeloda are mild to moderate with diarrhea (65%), palmar-planter erythrodysaesthesia (53%), rash (28%) nausea (44%), and vomiting (26%) occurring commonly.

Tyzeka for chronic hepatitis B

Tyzeka (Telbivudine)-Novartis-this newly approved drug is indicated for the treatment of adults with chronic hepatitis B (HBV) infections. It acts by inhibiting the HBV/DNA polymerase reaction necessary for viral replication. Its efficacy is comparable to that of Epivir-HBV. It is not a cure for HBV infections but can suppress the virus to the extent that symptoms are significantly reduced. Side effects are mild to moderate and include upper respiratory tract infections, fatigue,headache,abdominal pain and cough. A small number of patients may develop significant muscle weakness requiring discontinuation of Tyzeka.

Veregen for genital warts

Veregen (Kunecatechins)-Medigene-is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patient >18. In a large clinical study 53.6% of patients had complete clearance of their warts compared with 35.3% on a placebo ointment. Side effects are limited to the area of application and include itching, burning, swelling and occasional rash.

Vyvanse for ADHD

Vyvanse (Lisdexamfetamine)-Shire-after a number of years without any new drugs to treat Attention Deficit Hyperreactivity disorder (ADHD) Vyvanse is a needed addition to other amphetamine-like drugs in that category. A number of clinical studies have shown Vyvanse to produce a statistically significant improvement in behavior and when evaluated on the ADHD rating Scale (ADHD-RS-IV). Vyvanse will be indicated for the treatment of children ages 6-12. Although side effects are similar to those of the amphetamines and methylphenidate, this new drug does appear to have a lower potential for abuse.