A new nasal spray could soon be used to treat social anxiety disorder after the medication recently achieved late-stage clinical trial endpoints, which signals that it could soon receive FDA approval.
The nasal spray fasedienol comes from the biopharmaceutical company Vistagen and it was found to produce what experts called 'improved Subjective Units of Distress Scale scores' in patients undergoing a public speaking challenge, according to a press release. That means people who sniffed it quickly became less anxious.
The press release said that the nasal spray has now achieved top-line phase 3 trial results, which investigators believe may support a push for it to receive federal approval to treat patients with seasonal affective disorder, or SAD.
Vistagen shared that fasedienol, which is described as a first-in-class pherine nasal spray, may also provide fast-acting benefits to patients with SAD.
Vistagen chief executive officer Shawn Singh praised the capability of the nasal spray product in the press release, saying that it was revolutionary.
“As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas,” Singh said. “At the head of that class, fasedienol’s potential, as demonstrated in this phase 3 trial, sets the stage for the first fundamentally new class of medicine for individuals living with SAD in more than 20 years.”
According to the biopharmaceutical company, the medication could impact an estimated 25 million-plus Americans.
During the trial, 40% of those who received the drug reported seeing significant results, noting that they were “very much less anxious” or “much less anxious,” compared to 18.6% of those on the placebo.
Additionally, Vistagen shared that no severe or serious adverse events related to the medication were discovered through its trial.
As of now, Vistagen shared that an additional data analysis from its trial is ongoing and that the company intends to present the peer-reviewed results of the outcomes at upcoming scientific meetings.
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