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Weekly Drug News Round Up - June 4, 2014

Trimel Pharmaceutical’s Natesto Approved for Low Testosterone

Natesto is self-administered via a nasal applicator to lessen the risk of the gel coming into contact with women or children Read More…

Roughly 13 million American men may have low testosterone levels. This past week, the U.S. Food and Drug Administration (FDA) approved Natesto (testosterone), a gel product containing testosterone that is placed in the nose for the treatment of male hypogonadism (low testosterone or “Low-T”). The recommended dose of Natesto is 11 mg of testosterone (two pump actuations, one per nostril), applied intranasally three times daily for a total daily dose of 33 mg. In a 90-day clinical trial, 73 men were treated with 33 milligrams of intranasal testosterone daily and then evaluated. Ninety percent (90%) of these patients had testosterone levels within the normal range on day 90.

FDA Approves Omidria for Cataract Surgery and Lens Replacements

Omeros is expected to launch Omidria in the late summer/early fall of 2014 Read More...

The U.S. Food and Drug Administration (FDA) has approved Omidria (phenylephrine and ketorolac injection) 1% - 0.3% for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. Omidria is a combination product that contains a mydriatic (pupil-dilating) agent and an anti-inflammatory agent that is added to an irrigation solution. According to experts, the anti-inflammatory ketorolac in Omidria could reduce the need for preoperative NSAIDs. In clinical trials, side effects with Omidria were similar to placebo and included eye irritation, posterior capsule opacification, increased intraocular pressure and anterior chamber inflammation.

Celebrex Now Approved in a Generic Formulation

In 2013, Pfizer’s Celebrex brought in almost $3 billion in sales Read More...

Celebrex is a popular and widely prescribed COX-2 inhibitor NSAID used for pain and arthritis. The U.S. Food and Drug Administration (FDA) has now approved the generic version of Celebrex known as celecoxib. Teva Pharmaceuticals has gained the sole 180-day “first-to-file” exclusivity rights, and will market the celecoxib 100, 200, and 400 mg strengths. Mylan will have exclusive right on the 50 mg capsule for 6 months. Like all NSAID medications, generic celecoxib will have a Boxed Warning about the risk of heart attack or stroke that can lead to death. Teva will launch their generic versions by December 2014.

Anti-Alzheimer's Drug Shows Promise in Mice Study

Alzheimer’s disease, which has no cure, leads to loss of cognitive function such as memory and language Read More...

Alzheimer's disease is currently the most common form of dementia, affecting more than 5 million Americans. Alzheimer prevalence is expected to triple by 2050 if effective preventive treatments are not developed. As reported this week in the Annals of Neurology, researchers working with mice have identified a drug they believe holds promise as a preventive treatment for Alzheimer's disease. The agent, known as 2-PMAP, targets amyloid proteins and cuts the levels by about half. 2-PMAP has been non-toxic in mice, although effects in humans are not known yet. Researchers are hopeful the compound can be used long-term to help prevent Alzheimer’s disease in humans.

Melanoma Survival Rates Soar in Investigational Studies

New melanoma combos have severe side effects but researchers state the risk-to-benefit may be worth it Read More...

Investigational combination treatments for advanced melanoma - the deadliest form of skin cancer - are extending patient survival. Survival in patients with stage 3 and 4 melanoma has been extended with the approved drug Yervoy (ipilimumab), both on its own and in combination with another cancer drug. In one trial that utilized Yervoy plus an investigational agent nivolumab, the median survival of 53 patients with inoperable advanced melanoma was extended by three and one-half years. The combination therapy nearly doubled the overall survival found in previous studies of either drug alone.