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New Drugs, Indications, Dosage Forms, and Approvals

  • Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.1 This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.
  • IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.2 It is in early-stage clinical trials.
  • Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.3 It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.4
  • Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.5 Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.

Pipeline

  • Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.6 Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.
  • Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.7 At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.
  • Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.8
  • Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.9 Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.
  • Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).10 Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.
  • Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.11 It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.
  • Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).12 This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.13
  • Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.14 According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.
  • Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.15 It is in Phase 3 clinical trials for treating asthma. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

  1. FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
  2. ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
  3. CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
  4. Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
  5. Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
  6. Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
  7. Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
  8. INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
  9. Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
  10. Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
  11. Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
  12. Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
  13. Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
  14. US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
  15. Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.

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