New Drugs and Devices 2008

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Banzel for Lennox-Gastaut seizures

Banzel (Rufinamide) — Eisai — Banzel is the most recent addition to anticonvulsants indicated for the treatment of difficult to control seizures. In clinical studies, the administration of Banzel resulted in a 41% reduction in certain types of seizures and a 20% reduction in total seizures. The most common side effects were headache,dizziness, fatigue, and double-vision.

Cimzia for Crohn’s disease

Cimzia (Certolizumab) — UCB — this newly approved drug is indicated for patients with Crohn’s disease who have not responded to conventional therapy. It acts by blocking the substance TNF (tumor necrosis factor), a natural biochemical involved in thee inflammatory process. Common side effects include; headache, upper respiratory tract infections, abdominal pain and nausea. Because Cimzia affects the immune system it can lower the ability of the body to fight infections. Cimzia is given by injection every two weeks for the first three injections and then once every four weeks thereafter.

Degarelix for advanced prostate cancer

Degarelix — Ferring — this newly approved injectable drug for advanced prostate cancer owes it pharmacology to the blockade of the receptor site for gonadotropin-releasing hormone. Blockage of this hormone prevents the release of testosterone, a stimulant to the growth of prostate cancer. It appears to produce a castrate level of testosterone more quickly that the current product available for this use, leuprolide. At Day 3 of treatment fully 96% of patients had achieved castrate levels of testosterone.

Entereg for gastrointestinal paralysis following abdominal surgery

Entereg (Alvimopan) — Glaxo — this novel drug taken orally has been approved for the intestinal atony (partial paralysis) following partial large or small bowel resection. It acts as a opioid receptor antagonist. This blocks the adverse effect on intestinal motility commonly experienced when opiates are administered for postsurgical pain. His drug is highly restricted and available only to hospitals registered for the use of Entereg

Intelence for resistant HIV infections

Intelence (Etravirine) — Tibotec — this is a new non-nucleoside reverse transcriptor inhibitor (NNRTI) which is indicated for the treatment of HIV infections resistant to available NNRTI’s and other available anti-retroviral drugs. Side effects occur in >10% of patients and include rash (which resolves with continued use) and nausea. Other side effects include: diarrhea, abdominal pain, peripheral neuropathy and hypertension. Intelence should not be taken with any other NNRTI drug.

Kuvan for phenylketonuria

Kuvan (Sapropterin) — Biomarin — this is the first drug approved for the treatment of phenylketonuria (PKU). PKU is caused by a relative deficiency of tetrahydrobiopterin, a cofactor which works with phenylalanine hydrolyase to metabolize phenylalanine. Kuvan, which is given by mouth, is a form of tetrahydrobiopterin and thus increases the metabolism of phenylalanine thus potentially reducing the severe neurological damage which is common with PKU.

Latisse for eyelash growth

Latisse (Bimatoprost) — Allergan — this is the first product approved for use to promote eyelash growth. It is used as an ophthalmic solution. Side effects are mild with the most common side effect being eye redness, itchy eyes and hyperpigmentation of the eyelid. Further studies were recommended in patients who have lost their eyelashes to cancer chemotherapy. Available early 2009.

Mozobil for stem cell harvesting

Mozobil (Plerixafor) — Genzyme — this novel drug enhances mobilization of stem cells for autologous bone marrow transplantation in patients with non-Hodgkins lymphoma and multiple myeloma. Mozobil is used in combination with granulocyte-colony stimulating factor. This will be available in mid-2009.

Nplate for idiopathic thrombocytopenia

Nplate (Romiplostim) — Amgen — this is a significant new drug which is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Nplate, a peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease. Side effects include: Headache,joint pain,pain in arms and legs, and tingling or numbness in hands and feet.

Pristiq for depression

Pristiq (Desvenlafaxine) — Wyeth — this new drug is the major active metabolite of venlafaxine (Effexor). It is available in only one dose and does not require the titration necessary with most of the other antidepressants in its class. It may be useful for patients who don’t respond to venlafaxine at a low dose but develop side effects at higher doses.

Relistor for opioid-induced constipation

Relistor (Methylnaltrexone) — Wyeth — this is the first drug specifically approved for the reduction of the constipation induced by opioid drugs. This side effect is a common and often debilitating problem associated with the continuous use of opioid drugs used in the treatment of late-stage illnesses such as incurable cancer. Relistor is given once daily by injection every other day. Side effects include: abdominal pain, nausea, dizziness and diarrhea.

Tapentadol for pain

Tapentadol — J&J — this newly approved non-opioid drug is indicated for the treatment of moderate to severe pain. It is available as oral tablets. The mechanism of action differs from most other analgesics in that it combines mu-opioid receptor agonism with norepinephrine reuptake inhibition. Phase 3 studies focused on the usefulness of Tapentadol in orthopedic pain and in those trials, it was found to be as effective as strong opioids.

Toviaz for overactive bladder

Toviaz (Fesoterodine)-Pfizer-this new drug is structurally related to Detrol. Given once daily, it may be useful in patients who have side effects to Detrol. In a placebo controlled study, patients showed up to a 88% mean reduction in urge urinary incontinance. Side effects occurred in 19% of patient with dry mouth being the most common. This product will be available in early 2009.

Trilipix for elevated cholesterol

Trilipix (Fenofibric acid) — Abbott — Trilipix is a new formulation of fenofibric acid differing from the earlier Abbott drug, TriCor, in that it is a delayed release product.

Vimpat for partial-onset seizures

Vimpat (Lacosamide) — Swartz — this new drug entity has been approved for adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy over 17 years of age. Studies which led to the approval of this drug Vimpat reduced the number of seizures by 50% and also reduced the median seizure frequency. The most common side effect included: blurred vision, headache, nausea, and nausea. Similar to other anticonvulsants, Vimpar may increase the risk for suicidal behavior.

Xenazine for Huntington’s disease

Xenazine (Tetrabenazine) —Prestwick — this is a significant new drug which acts to reduce the involuntary muscle movements characteristic of Huntington’s disease. It acts by depleting brain stores of dopamine. Proper dosing requires a slow titration upwards at weekly intervals up to a maximum of 50 mg daily. The most common side effects are: insomnia, depression, restless and nausea. The depression can be serious enough to include suicidal thoughts.

Zolpimist for insomnia

Zolpimist (Zolpidem) — NovaDel — this is a new route of administration for the popular sleep-inducing drug Zolpidem. Previously only available as tablets this new dose form is an oral spray. Clinical studies have shown equivalence with the tablets. Although not stated in the announcement of FDA approval it is likely that this dose for would be more rapid in action than the oral tablets.