The FDA has fast-tracked for potential approval a derivative of the party drug ketamine for major depression. The drug, esketamine, is being developed by Janssen Pharmaceutical as a nasal spray. One of the reasons esketamine has been generating a lot of excitement is that research has shown the therapeutic effects of the drug can be felt within hours or days of taking it. With currently available antidepressants, therapeutic effects can take many weeks, if not longer. The FDA’s Breakthrough Therapy Designation (BTD) for esketamine is for major depression with imminent risk of suicide, for which there is no approved treatment. Two years ago, the drug received BTD for treatment-resistant depression. Janssen has previously said it expects to have Phase III data in hand in 2018 and submit the drug to the FDA for approval that year. Posted August 16, 2016. Via Janssen Pharmaceutical.
A new opioid under development may be as effective as morphine without the side effects associated with other prescription opioids and also have a low risk of addiction. The drug, PZM21, is still in the early stages of development, and so far has only been tested on mice. However, initial studies showed that PZM21 was able to target receptors in the brain to reduce pain signaling, but without causing breathing problems and constipation that are common side effects of other opioids. In addition, the drug did not stimulate the dopamine regions in the brain — where the reward system is located — so there is the potential for PZM21 to be a less-addictive opioid. Posted August 17, 2016. Via University of California San Francisco.
Erectile dysfunction (ED) drugs do not increase the risk of prostate cancer, according to new research. Researchers looked at data from a study examining the use of Avodart (dutasteride) in men with enlarged prostates at risk of prostate cancer. About 5.6% of men were taking an ED drug such as Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenafil). During the trial, 19.5% of men taking an ED drug were diagnosed with prostate cancer compared to 22.7% of men who did not take one of the drugs. The difference was not considered clinically significant. They found some correlation between ED drug use and lower prostate cancer diagnosis in North American men, though the effect was not statistically significant. Posted August 1, 2016. Via EurekaAlert.