Despite the critics’ demand to further the study and research, the United States Food and Drug Administration has approved Janssen Pharmaceuticals Inc.’s drug-based nasal spray that could be the solution to life-threatening implications of treatment-resistant depression.
Called the Esketamine, the chemical cousin of Ketamine popularly known for being illegally used as a club drug, it will be sold in the form of a nasal-spray brand called Spravato—to be taken with an oral anti-depressant. What makes this drug different are its additional effective faculties for treatment-resistant depression.
To prevent potential misuse and abuse, the nasal spray will be available through restricted distribution system, and must be administered by an approved health care provider. If self-administered, it must still be under the supervision of a health care professional. Either way, the administration can happen only in a certified medical office—never at home—where the patient can be monitored for at least two hours after being given the drug.
As it is a nasal-spray, the drug goes through the nose and into the blood stream. Compared to other anti-depressants which can take weeks to have an effect, Spratavo is rapid-acting with effects within hours or days observed during its clinical trials. However, it comes with risks and side effects that include (but not limited to): impairment of attention, judgment, thinking, reaction speed, and motor skills. The drug also comes with a Boxed Warning that cautions the probability of behavioural change and suicidal thoughts.
Amid the controversies, often related to the lack of long-term data on its health effects, this sheds a new light in the endless pursuit to study the human mind.
According to the World Health Organization, about 300 million people suffer from depression worldwide. Spratavo aims to cater to the 30% to 40% patients who’ve been prescribed with the conventional and currently available treatment for major depression but yielding to minimal or zero success.
As of writing, no date has been confirmed yet as to when the medicine will be made available in the market, in consideration to the comprehensive strategic planning prior to release.
Story based on FDA news release.
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