June 21, 2019
FDA approves a new medication for a subgroup of women with hypoactive sexual desire disorder
The U.S. Food and Drug Administration announced today that it has granted approval of bremelanotide (brand name Vyleesi™) to AMAG Pharmaceuticals for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
A key point to note is that this is a subcutaneous injection to be used on an as-needed basis. It will be available in an autoinjector and the medication would be injected subcutaneously at least 45 minutes before sexual activity is anticipated.
The full wording of the FDA indication is as follows (emphasis added):
“VYLEESI is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
– A co-existing medical or psychiatric condition,
– Problems with the relationship, or
– The effects of a medication or drug substance.”
The Prescribing Information also notes:
“Limitations of Use:
– Not indicated for treatment of HSDD in postmenopausal women or in men.
– Not indicated to enhance sexual performance.”
Note that the FDA indication is for “hypoactive sexual desire disorder (HSDD)” that is “acquired” and “generalized.” Let’s clarify what these terms mean.
What is hypoactive sexual desire disorder (HSDD)?
HSDD is a DSM-IV diagnosis (now subsumed in DSM-5 under “Female Sexual Interest/ Arousal Disorder“) that is characterized by low sexual desire that is associated with marked distress and interpersonal problems and NOT associated with a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other substance.
What is “acquired” HSDD?
The FDA-approved Prescribing Information says that “Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire.” This is not correct as stated. Actually, it is not that the woman can never have had problems with sexual desire in the past. “Acquired” means that the problem has not been lifelong, that is, present since the woman became sexually active. Instead, the woman had at least some period of time during which she had relatively normal desire and THEN she developed this low desire.
What is “generalized” HSDD?
Generalized HSDD is HSDD that occurs irrespective of the type of sexual activity, situation, or partner.
How is bremelanotide to be administered?
Bremelanotide can be self-administered by injecting under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity.
Patients should not administer bremelanotide more than once per 24 hours or more than eight times per month. If no improvement in sexual desire is experienced after 8 weeks of treatment, patients should discontinue treatment.
What are its potential side effects?
Nausea and vomiting, flushing, injection site reactions, and headache are the most common side effects associated with bremelanotide. Nausea was reported by about 40% of patients and 13% needed medications for the treatment of nausea.
Other side effects include darkening of the gums and part of the skin, especially in patients with dark skin, and increase in blood pressure after dosing which usually resolves in 12 hours.
The FDA’s announcement about the approval of bremelanotide (Vyleesi™) is available HERE.
The full Prescribing Information for bremelanotide (Vyleesi™) is available HERE.
April 11, 2019
Women taking “the Pink Viagra” can now drink (with precautions)
The FDA has modified the safety warning regarding alcohol use in patients taking flibanserin (brand name Addyi®).
Flibanserin is an FDA-approved medication for the treatment of premenopausal women with acquired,
generalized hypoactive sexual desire disorder (see https://simpleandpractical.com/flibanserin-addyi/). The media has sometimes referred to it as the “Pink Viagra.”
Before the change: Cases of severe hypotension and syncope had been reported when flibanserin and alcohol were taken together. So, when flibanserin was first approved by the FDA in 2015, it carried a boxed warning stating that alcohol must be avoided by women taking flibanserin. The clinician prescribing the flibanserin was required to counsel the patient, using a Patient-Provider Agreement Form, about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol while taking flibanserin. The pharmacist was also required to counsel the patient about not drinking alcohol while taking flibanserin.
After the change: The FDA has said that the product label should be changed “to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely.”
According to the FDA’s press release (linked to below), postmarketing trials showed that “the risk of severe hypotension and syncope was reduced when women who consumed up to two alcoholic drinks waited at least two hours before taking Addyi.”
The FDA’s press release notes that “women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.”
March 20, 2019
First drug approved by the FDA specifically for postpartum depression
Wow! Two new drugs approved by the US Food and Drug Administration (FDA) for depressive disorders in the same month! What is even more interesting is that both of these have pharmacological effects that are different from the antidepressants that we have been prescribing for decades. On March 5, 2019, the FDA had announced the approval of esketamine (brand name Spravato). Yesterday, the FDA announced the approval of brexanolone (brand name Zulresso) injection for intravenous use for the treatment of postpartum depression.
Note that this is the first medication that has been approved by the FDA specifically for the treatment of postpartum depression.
What is so special about brexanolone? Not that it is more effective than other antidepressants but that it works very quickly–in just a couple of days–so that, if it works, the mother could potentially be back quickly with her baby and with less or no depression.
One limitation is that brexanolone will have to be given as a continuous intravenous infusion over 60 hours, that is, 2.5 days. Also, just like esketamine, brexanolone will also carry a Boxed Warning and will have to be prescribed through a special Risk Evaluation and Mitigation Strategy (REMS) program. What this means is that it will only be available at health care facilities that have been specifically certified through the brexanolone REMS program and the patient’s information will have to be registered with the REMS program before the treatment is given. Why? Why is a special REMS program needed? Because there is a concern that excessive sedation or sudden loss of consciousness can occur while the intravenous injection of brexanolone is being given. Because of this risk, patients will have to be carefully monitored during the infusion and continuous pulse oximetry monitoring will have to be done (which is easy to do, of course). Also, while the infusion is being given, the mother will have to be supervised while interacting with her children.
Other than possible sedation and loss of consciousness, other side effects reported with brexanolone were dry mouth and flushing.
Subscribers to Simple and Practical Mental Health will receive brief summaries about what brexanolone is, how it works, how well it works, and so on.
March 5, 2019
FDA approves esketamine nasal spray (brand name Spravato) for “treatment-resistant depression”
The U.S. Food and Drug Administration (FDA) announced today that it has approved esketamine nasal spray (brand name Spravato) for marketing in the US. Here are some basic details about this medication:
– What is esketamine? It is one of the two enantiomers in the medication ketamine, which has been available in the US since 1970 and is FDA-approved for use as a general anesthetic.
– Esketamine nasal spray is approved for the treatment of major depressive disorder in persons who have taken other antidepressant medications but have not benefited from them, so-called “treatment-resistant depression.”
– It is approved not for monotherapy but for adjunctive use along with an oral antidepressant medication.
– It is approved for use in adults only
– Not everyone will be able to prescribe esketamine nasal spray. Similar to medications like clozapine and flibanserin, esketamine nasal spray will only be available by prescription from clinicians registered under a Risk Evaluation and Mitigation Strategy (REMS) program. This is because serious adverse events can occur due to sedation and dissociation caused by esketamine and due to the potential for abuse.
– The manufacturer of Spravato is Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson.
– Members of Simple and Practical Mental Health will receive a detailed review of this medication, the research behind, the potential risks, and so on.
The FDA’s announcement is available at the link below:
The full Prescribing Information is available at the link below:
Disclosure: Dr. Mago bought some J&J stock (less than $7000 worth) and, as in almost all his investments, has lost money on it! 🙂 He does not have any other association, financial or otherwise, with Janssen Pharmaceuticals, Inc, or its parent company, Johnson & Johnson.
Feb 13, 2019
Esketamine nasal spray on verge of being approved by the FDA
The FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted in favor of approving esketamine nasal spray (brand name Spravato) for approval to treat major depressive disorder that not responded to other treatments. The exact wording of the indication will be announced if the drug is approved. What also remains to be seen is what special precautions or Risk Evaluation and Mitigation Strategy (REMS) the FDA will require. The FDA’s decision is expected on March 4, 2019, but the FDA usually follows the advice of its advisory committees. For details of the announcement and for the full document that was presented to the committees, see the links below:
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