June3

The problem with ordering prescription drugs from online pharmacies, is that you have no idea what you’re getting. Just ask the woman from this recent CNN Health article.
“Every night before her husband went to bed, he would open a prescription bottle of the muscle relaxant Soma and swallow the eight or nine pills it took for him to fall asleep, said the woman.”
The truth of the matter is, there are no shortage of online pharmacies out there from which to order. So the question becomes, what drives people to order from them? Do we need to make certain drugs more accessible here in the United States, or will that only exacerbate the existing problem? It almost seems like it would be better to take these drugs under the supervision of a doctor, even if they are habit-forming - especially if people can just get their hands on them elsewhere.
It’s just so easy for people to learn about various drugs from sites like rxlist.com and webmd.com and the go order those drugs from foreign pharmacies. And while U.S. Customs does what it can to control the influx of illegal prescription drug orders, the sheer volume is simply overwhelming. I’m not sure what the solution is, but there is no question that people are engaging in risky behavior when they are ordering online. There is no guarantee that you are even getting the drug that you think you are getting, and you don’t have a doctor to supervise any potential negative reactions or bad drug interactions. And yet, despite these glaring risks, people order online 24 hours a day, seven days a week.
June3
Here are the most recent drug applications submitted to the FDA for approval. I always find it interesting to see what’s coming our way.
- Sancuso (granisetron) Transdermal Patch Company: ProStrakan Group; Treatment for: Nausea/Vomiting - Chemotherapy Induced. Sancuso (granisetron) is an anti-emetic transdermal delivery system in development for the treatment of chemotherapy-induced nausea and vomiting without the need for injections or swallowing pills.
- Promacta (eltrombopag): Company: GlaxoSmithKline; Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura. Promacta (eltrombopag) is an investigational oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding.
- Liraglutide Company: Novo Nordisk; Treatment for: Diabetes Mellitus Type II. Liraglutide is a once-daily human GLP-1 analogue in development for the treatment of people with type 2 diabete
- Rezonic (casopitant): Company: GlaxoSmithKline; Treatment for: Nausea/Vomiting - Chemotherapy Induced, Nausea/Vomiting - Postoperative. Rezonic (casopitant) is an investigational NK-1 receptor antagonist in development as add-on therapy for the prevention of chemotherapy-induced nausea and vomiting, and also for the prevention of postoperative nausea and vomiting.
- Surfaxin (lucinactant). Company: Discovery Laboratories, Inc. Treatment for: Respiratory Distress Syndrome. Surfaxin, an engineered version of natural human lung surfactant, represents a potential alternative to the commercially available animal-derived surfactants used for the prevention of Respiratory Distress Syndrome in premature infants.
- OTG (oxybutynin hydrochloride) Topical Gel. Company: Watson Pharmaceuticals, Inc. Treatment for: Overactive Bladder
- Viviant (bazedoxifene). Company: Wyeth Pharmaceuticals. Treatment for: Prevention of Osteoporosis. Viviant (bazedoxifene) is a selective estrogen receptor modulator (SERM) in development for the prevention of postmenopausal osteoporosis.
- Davanat Company: Pro-Pharmaceuticals, Inc. Treatment for: Targeted Drug Delivery. Davanat is a polysaccharide polymer comprised of mannnose and galactose in development for the targeted delivery of drugs used in the treatment of cancer.
- Reloxin (botulinum toxin type A) Company: Ipsen and Medicis. Treatment for: Aesthetics. Reloxin (botulinum toxin type A) is a neurotoxin in development for the temporary improvement in the appearance of some facial wrinkles.
- Iclaprim Intravenous Injection. Company: Arpida Ltd. Treatment for: Skin and Structure Infection. Iclaprim is a broad-spectrum diaminopyrimidine antibiotic in development for the treatment of complicated skin and skin structure infections.
- Sublinox (zolpidem) Sublingual Tablets. Company: Orexo and Meda AB. Sublinox is a sublingual tablet formulation of the widely used drug zolpidem. Sublinox is being developed to provide fast, effective absorption for the short term treatment of insomnia.
- Entereg (alvimopan) Capsules. Company: Adolor Corporation. Treatment for: Postoperative Ileus. Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.
- Cinryze (C1 inhibitor). Company: Lev Pharmaceuticals, Inc. Treatment for: Angioedema. Cinryze is a C1-esterase inhibitor being developed as a comprehensive replacement therapy for the treatment of hereditary angioedema (HAE).
- Naturlose (tagatose). Company: Spherix Incorporated. Treatment for: Diabetes Mellitus Type II. Naturlose (tagatose) is a unique sugar undergoing clinical trials as a treatment for Type 2 diabetes.
- Imagify (perflubutane). Company: Acusphere Inc. Imagify is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease.
- MK-0524A (niacin ER and laropiprant) - formerly Cordaptive. Company: Merck & Co., Inc. Treatment for: Hyperlipoproteinemia Type IIa (Elevated LDL), Hypertriglyceridemia. MK-0524A is an investigational compound containing extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. MK-0524A is used either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglyceride levels.
June3

Vion Pharmaceuticals announced the interim data results of its pivotal phase II trial of cloretazine, an anticancer agent drug that is intended to treat elderly patients with de novo poor-risk acute myelogenous leukemia (AML) today. 35 percent of the 85 patients evaluated in the study responded to the drug treatment, and 90 percent of those responses occurred after the first induction treatment.
“While follow-up is still ongoing, the median of overall survival for responders was 6.3 months (1.7-16.4 months) and for all patients was 3.2 months (0.1-16.4 months). The induction death rate within 30 days of first induction treatment was 14 percent. The majority of first induction deaths were either due to progression of disease or infection.”
In a Vion Pharmaceuticals press release, Dr. Gary Schiller, Professor of Medicine at the David Geffen School of Medicine, and a lead investigator on the study, said “The responses observed in this trial represent a clinically meaningful outcome for many of these difficult-to-treat AML patients. As a single-agent, single-infusion therapy, Cloretazine has the potential to be an important new treatment option for older patients with poor-risk AML.”
Alan Kessman, Chief Executive Officer of Vion Pharmaceuticals, said the company plans to file an application for new drug approval with the FDA some time this year.
AML is the most common type of leukemia, and more than 11,900 new cases occur in the United States each year, mostly in older adults. My grandmother died from this cancer when she was only 63, so I know she could have had many more good years in her life, had there been an effective treatment available. So here is another example of the kind of drug research that could potentially perform miracles.