Axsome Therapeutics reported on November 2 that new-to-brand prescriptions for Auvelity among patients aged 65 and older grew 211 percent in the third quarter from a year earlier. New-to-brand prescriptions, which the company calls new patient starts, grew 44 percent for the drug overall. Compared with the second quarter, the 65-and-older group grew 99 percent and the drug overall 21 percent.
July through September was the first full quarter after the FDA approved Auvelity on April 30 for agitation associated with dementia due to Alzheimer’s disease, an indication Axsome launched commercially in June, according to its second-quarter report. Auvelity was already approved for major depressive disorder in adults. On the company’s figures, a group growing faster than the whole must be taking a larger share of it, so older patients are a bigger part of new starts than they were. Axsome’s release does not say how big a part, and it does not separate the two indications.
What the 211 percent shows, and what it does not
The company reports the age-cohort figures as growth rates only. Its release gives total Auvelity prescriptions of about 302,000 in the quarter, up 40 percent year over year and 14 percent sequentially, and the same two periods for patients 65 and older: total prescriptions up 101 and 43 percent. It gives no count of 65-and-older prescriptions, and the quarter’s older-patient share is not stated anywhere in the release or the earnings presentation. Axsome’s presentation sources its prescription charts to Symphony METYS; the release does not name the source of the age-cohort figures.
The figures can still be bounded. Behavioral Wire’s arithmetic: the 99 percent against 21 percent means the older group’s share of new starts rose by a factor of about 1.6 in one quarter, and the 211 against 44 percent means about 2.2 times a year earlier. If new starts under 65 did not fall from the second quarter, the older group was at most about a fifth of second-quarter new starts and is at most about a third now. The presentation says prescription growth continued under 65 but does not give the figure or the period, so that condition is an assumption. Either way, the older group is a minority of starts that is growing quickly, not a majority.
Nor do the data say what is driving it. Age-cohort prescriptions cannot separate agitation from depression, and older adults get depression. Axsome’s chief executive said the company expects sustained momentum from demand in depression and “continued acceleration of new patient initiations” in agitation. The presentation says the agitation momentum “reflects underlying MDD growth and early impact from the sales force expansion,” and reports newly activated prescribers up 19 percent from the second quarter. Those are the company’s readings of its own data, not a measured split. By the company’s measure, access is not an obvious constraint: Auvelity’s payer coverage is about 89 percent of lives overall and about 100 percent of government lives, which the release defines as Medicare and Medicaid.
What the older-adult evidence shows
For the agitation indication, older adults are the studied population by design. The label’s two efficacy studies, both Axsome’s, enrolled patients 65 and older. Study 3 randomized 152 patients to Auvelity and 156 to placebo for five weeks; the median age was 75, with a range of 65 to 90. The Cohen-Mansfield Agitation Inventory, a caregiver-based score running from 29 to 203, fell 3.3 points more on Auvelity (95 percent confidence interval 0.8 to 5.8). Study 4 randomized patients who had already responded to continue Auvelity or switch to placebo for up to six months, with a median age of 73 and a range of 65 to 89, and found a longer time to relapse among those who continued. It tests keeping a response, not starting a patient who has not been selected for one.
The label reports 720 patients aged 65 and older among those treated in the agitation studies, 368 aged 65 to under 75 and 352 aged 75 and over. It states that no overall differences in safety or effectiveness were observed between these patients and younger subjects, and also that greater sensitivity in some older individuals cannot be ruled out. In Study 3, dizziness was reported by 9 percent on Auvelity and 3 percent on placebo, somnolence by 8 and 4 percent, a confusional state by 3 and 1 percent, and psychotic symptoms by 3 and 0 percent. Prescription growth is not outcome evidence, and nothing in the quarter’s figures speaks to how older patients do on the drug outside the trials.
What the label adds for older patients
The April revision also added a hyponatremia warning, section 5.10. It says hyponatremia has occurred with Auvelity, cites one premarketing case with a serum sodium of 115 mmol/L, and states that “geriatric patients may be at greater risk.” The label’s geriatric-use section goes further, saying Auvelity “has been associated with clinically significant hyponatremia in geriatric patients.” The warning lists headache, confusion, weakness and unsteadiness that can lead to falls among the signs, and notes that severe cases have ended in death. It names concomitant serotonergic antidepressants, diuretics and volume depletion as added risks. The label gives no incidence, so the size of the risk in practice is not stated. A separate dizziness warning advises precautions against falls.
Auvelity is not the first drug approved for this indication: the FDA approved Otsuka and Lundbeck’s Rexulti, an antipsychotic, in May 2023. Rexulti’s label carries a boxed warning of increased mortality in elderly patients with dementia-related psychosis. Auvelity’s only boxed warning is for suicidal thoughts and behaviors in pediatric and young adult patients, and the phrases “dementia-related psychosis” and “increased mortality” appear nowhere in its label. Both labels state the drug is not indicated as an as-needed treatment for this agitation. That is a label difference, not a safety comparison. The label cites no head-to-head trial, and the programs differ: Rexulti’s two trials ran 12 weeks and enrolled patients 51 to 90, against Auvelity’s five-week Study 3 in patients 65 to 90.
What it has done to revenue so far
Auvelity net sales were $207.6 million, up 52.5 percent from $136.1 million a year earlier and 15.2 percent from $180.3 million in the second quarter. Behavioral Wire’s arithmetic on the second-quarter filing: sales had grown 50.7 percent year over year in that quarter, and 18.1 percent sequentially. The agitation launch is not yet visible as a step up in revenue growth. Revenue lags new starts, and the filings do not disclose the effect of gross-to-net adjustments or inventory, so that is an observation and not a verdict.
Axsome’s headline calls $259.7 million “total net product revenue,” up 52 percent. Its statement of operations splits that figure into $250.0 million of product sales and $9.7 million of royalty and milestone revenue, including an $8.5 million Sunosi milestone with no counterpart in the year-ago quarter. Product sales alone grew 47.2 percent, from $169.8 million. Auvelity was 83.1 percent of product sales, against 83.3 percent in the second quarter, so the added indication has not changed how much of the company rests on one product. The next dated event that could is AXS-12’s FDA action date for cataplexy in narcolepsy, set for May 1, 2027.
Selling, general and administrative expense was $203.1 million, up 35 percent, which the company attributes to commercialization of Auvelity and Symbravo; it was 78 percent of total revenue. Net loss narrowed to $12.9 million from $47.2 million. Cash and cash equivalents were $313.9 million at September 30, against short-term borrowings of $70.0 million and a long-term loan of $118.1 million, and Axsome says current cash is sufficient to fund operations into cash flow positivity, with no date or runway attached. Accounts receivable rose to $343.1 million, $65.7 million of that in the quarter, and accrued expenses to $331.8 million from $232.9 million at year end. The release has no cash flow statement, aging or gross-to-net detail, so what drove either is not stated. The quarterly report for the period, not filed as of November 2, is where it can be read.
What would settle the older-patient question is a count: how many of Auvelity’s new starts are 65 and older, and how many of those are in agitation. Until Axsome gives one, the disclosure shows the direction of mix, and the label shows what that direction carries.