Vyleesi (bremelanotide) actually has a long and interesting history. It started as a sunless tanning product (Melanotan 2) which was administered via a nasal spray. When the male test subjects experienced spontaneous erections Palatin decided that might be a more interesting product and modified the molecule to eliminate the tanning part and keep the libido part. The product, PT-141, is sold around the world and has been used by a select number of men and women to enhance their sexual experiences safely for years. The US FDA banned it because the nasal spray approach caused significant blood pressure increases but the subcutaneous injection approach is considered safe because the dosing is better controlled.
There is no medical question that given the appropriate dose bremelanotide will result in very real physiological changes related to sexual arousal in men and women. One concern that I have with the choice of AMAG to go with the 1.75mg dose in the autoinjector is that it may be insufficient for some women who will not get the full arousal effect with less than 2.0mg. They chose this as a compromise between efficacy and the side effects of nausea that some women experience with the initial uses. There are actually pilot studies underway to determine if Vyleesi can be taken with Zofran if needed to eliminate the nausea. This was not an option with the clinical trials because it would have confounded the results. The nause is reduced or disappears with additional doses as the body adjusts.
What has fascinated me about this class of drugs is the reaction of many women and men that this drug should not be approved even if it works! The FDA explicitly noted in their Prescribing Guidelines that it should not be prescribed to improve sexual enjoyment. Who the hell is the FDA to tell women that they shouldn't be able to improve their enjoyment of sex if they are informed and it is deemed safe? The question that remains is: Will women be cowed by the matriarchy and patriarchy into once again suffering in silence for their illicit desires or will they take control of their bodies and decide for themselves how they want to experience life. It will not work the same for everybody and may not be the answer for some. There is a strong interest by postmenopausal women for a drug like this and further study is needed to ensure that issues of age related hypertension or low female hormone levels don't reduce its safety or efficacy metrics. The final arbiters of whether Vyleesi succeeds or not should be the women who try it and determine if it improves this aspect of their lives not the pundits and stock analysts and medical experts that have never even tried the drug.
dwrightsd says...
Vyleesi (bremelanotide) actually has a long and interesting history. It started as a sunless tanning product (Melanotan 2) which was administered via a nasal spray. When the male test subjects experienced spontaneous erections Palatin decided that might be a more interesting product and modified the molecule to eliminate the tanning part and keep the libido part. The product, PT-141, is sold around the world and has been used by a select number of men and women to enhance their sexual experiences safely for years. The US FDA banned it because the nasal spray approach caused significant blood pressure increases but the subcutaneous injection approach is considered safe because the dosing is better controlled.
There is no medical question that given the appropriate dose bremelanotide will result in very real physiological changes related to sexual arousal in men and women. One concern that I have with the choice of AMAG to go with the 1.75mg dose in the autoinjector is that it may be insufficient for some women who will not get the full arousal effect with less than 2.0mg. They chose this as a compromise between efficacy and the side effects of nausea that some women experience with the initial uses. There are actually pilot studies underway to determine if Vyleesi can be taken with Zofran if needed to eliminate the nausea. This was not an option with the clinical trials because it would have confounded the results. The nause is reduced or disappears with additional doses as the body adjusts.
What has fascinated me about this class of drugs is the reaction of many women and men that this drug should not be approved even if it works! The FDA explicitly noted in their Prescribing Guidelines that it should not be prescribed to improve sexual enjoyment. Who the hell is the FDA to tell women that they shouldn't be able to improve their enjoyment of sex if they are informed and it is deemed safe? The question that remains is: Will women be cowed by the matriarchy and patriarchy into once again suffering in silence for their illicit desires or will they take control of their bodies and decide for themselves how they want to experience life. It will not work the same for everybody and may not be the answer for some. There is a strong interest by postmenopausal women for a drug like this and further study is needed to ensure that issues of age related hypertension or low female hormone levels don't reduce its safety or efficacy metrics. The final arbiters of whether Vyleesi succeeds or not should be the women who try it and determine if it improves this aspect of their lives not the pundits and stock analysts and medical experts that have never even tried the drug.
On 'Viagra' for women
Posted 29 July 2019, 4:17 p.m. Suggest removal