New Drugs of 2010

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It takes an average of 12 years and about 350 million dollars to get a new drug from the laboratory onto the pharmacy shelf. Once a company comes up with a drug, it undergoes around three and a half years of laboratory testing before an application is made to the FDA to begin testing on human subjects. Only one in 1,000 of the compounds that enter laboratory testing will ever make it to human testing. Here are some of the prescription drugs that made that journey to approval in 2010.

Vimovo (naproxen + esomeprazole) is a combination drug for arthritis in patients at risk for NSAID-associated ulcers. Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used to treat arthritis. Like other NSAIDs, such as ibuprofen and acetaminophen, it works by decreasing a substance involved in inflammation called prostaglandin. Unfortunately, prostaglandins have another role in the body; they protect the lining inside the stomach. So when we give drugs such as naproxen for pain, inflammation, and arthritis, this can slowly deteriorate this stomach layer. That's where esomeprazole comes in. Similar to the popular drug Prilosec, esomeprazole helps preserve the stomach's protective lining while allowing naproxen to work its anti-inflammatory action.

Jalyn (dutasteride + tamsulosin) is combination drug for the treatment of benign prostatic hyperplasia (BPH). BPH is an enlargement of the male prostate which affects 50% of men over 50 years old. This enlargement causes restricted urine flow, frequent low-volume trips to the bathroom, and discomfort. Both tamsulosin and dutasteride are currently available separately as treatments for BPH. Jalyn simply combines the two medications into one. They each work via different mechanisms. The prostrate resides around the urethra, through which urine flows on its way out. Tamsulosin stimulates receptors found in prostate and bladder tissues that cause relaxation, which produces less restriction, better urine flow, and reduced symptoms. Dutasteride blocks the formation of a hormone also involved in the enlargement of the prostate. Studies showed that this combination works significantly better than either of the two drugs alone.

Staxyn (vardenafil HCl) orally disintegrating tablets:
You may have already heard of a drug called Levitra (vardenafil) for erectile dysfunction (ED) in men. Staxyn is this same active ingredient in a rapidly disintegrating tablet. The tablet dissolves on the tongue without water, allowing a faster delivery of the drug to the circulation.

Victoza (liraglutide) is a once daily injection as an adjunct to diet and exercise for the treatment of type 2 diabetes mellitus. Victoza works on cells in the pancreas to increase insulin release in the presence of increased blood sugar levels. It also delays gastric emptying, thereby slowing the spike in blood sugar after meals.

Silenor (doxepin) is for the treatment of insomnia. The active ingredient in Silenor, doxepin, has been around for decades. It was used as an antidepressant in various strengths. In Silenor, the dose is very small as compared to the antidepressant dose. It's taken as one 3 or 6mg tablet 30 minutes before bedtime. Silenor, unlike many of the treatments for insomnia, is non-addictive.

Sprix (ketorolac tromethamine) is a non-narcotic nasal spray for moderate to moderately severe pain at the level where opioids would be considered. Already on the market in injection and tablet form under the brand name Toradol, ketorolac is a NSAID for short term use (up to 5 days only). Sprix offers patients a convenient dosage form for treatment of pain without the worries that come with prescribing narcotics, such as dependence and addiction.

Exalgo (hydromorphone hydrochloride) is a narcotic analgesic. Hydromorphone has been around for awhile under the brand name Dilaudid and as generic. Exalgo is formulated as an extended release tablet for moderate to severe pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The tablets are given once daily, and must not be crushed or chewed to avoid immediate release of a high dose of narcotic.

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