When first sitting down to interview Jeff Jonas, M.D., I will admit to being a bit skeptical. Jonas is the CEO of Sage Therapeutics, a company developing products for markets and therapeutic categories for which I had previously been very familiar — women’s healthcare and CNS. Having spent 17 years in pharma field sales, I had extensive experience calling on OB/Gyns, GPs, and FPs with novel products (e.g., NuvaRing, a small, flexible circular piece of plastic self-inserted into the vagina to provide monthly birth control), as well as experience detailing the anti-depressant mirtazapine, a noradrenergic and specific serotonergic antidepressant (NaSSA). Regarding antidepressants, I know how difficult it was to educate physicians on the different product mechanisms of action. Detailing NuvaRing (as a male) in offices predominately staffed by women provided consistent opportunities to overcome skepticism and resistance to a novel, low-dose, and convenient method of birth control.
Sage Therapeutics’ lead compound, brexanolone, is in the process of seeking an FDA approval for postpartum depression (PPD). As early trial results were significant enough to be granted an FDA Breakthrough Therapy Designation (BTD), my skepticism was less around whether or not the product may work, and more around its delivery (i.e., IV administration over a 60 hour period). I saw lots of challenges and obstacles to adoption should the product gain approval.
While much of Jonas’s insight will be shared in the July feature, not all could be included in our monthly print edition. As a result, I developed a two articles for Life Science Leader’s online exclusive section, Beyond The Printed Page. Subscribe to our monthly magazine here to get access to insightful and interesting feature articles like the one on the CEO of Sage Therapeutics. We hope you enjoy this latest Beyond The Printed Page installment.
Who Do You See As Being The Primary Prescriber For Brexanolone And Why?
That’s something we’re working through, as there is no classical pathway for women suffering from PPD, and there’s no approved therapy. Current therapies include psychotherapy and SSRIs, neither of which is overly effective and often require chronic interventions. We’ve had good response in working with the OB/GYNs, especially when engaging with the leadership of the American College of Obstetricians and Gynecologists (ACOG). Sage is also working with psychiatrists and pediatricians. That being said, probably a more important question is thinking about where is the appropriate site of care for the administration of brexanolone for women suffering from PPD. This is because the medication requires an IV infusion over 60 hours. I believe this to be a good example of how we need to rethink the treatment of depression. Some women, if diagnosed rapidly, may wish to be treated in the hospital shortly after delivery. Others may wish to go home and be treated at home. While those pathways may diverge in terms of which physicians are involved, the woman and the treatment will be the same. We are now exploring opportunities for home therapy, intermediate care therapy, as well as in-hospital therapy. Much will depend on where the woman’s preference lies and what’s most appropriate for the patient. From our experience in clinical trials, there’s no resistance to people coming in for a 60- hour treatment when there is the potential of getting better within the same timeframe.
How About Childcare Issues For A Single Parent Needing Brexanolone?
Site flexibility will likely be very important for effective treatment. But it is important to remember that these patients are not incapacitated during therapy, but perfectly ambulatory. A worst case scenario could be the patient at home with an IV strapped to their arm while wearing a small infusion pump. That being said, you can’t overestimate the value of early detection. In California for example, there is a movement to mandate screening for PPD, and the earlier the detection, the more convenient treatment. After all, you’re looking at dealing with a low-volume IV bag being hung for 60 hours, and that’s the end of your therapy. It is important to not minimize the significance of PPD just because its depression or childcare challenges faced by a single mother. For example, if you had a single mom with hyperemesis gravidarum (a condition characterized by severe nausea, vomiting, weight loss, and electrolyte disturbance) you’d treat the disease somehow, without getting hung up on childcare. This goes back to the major issue that we as a society have to deal with. PPD is a form of depression that is a medical complication of childbirth, not simply something that is psychosocial.
Do You Think Insurers Will Be Willing To Pay For Brexanolone, Or Require Patients To Fail On Other Generic Anti-Depressants First?
We’ve had good responses in our meetings with payers, with the caveat that they are obviously interested in their bottom line. But it is important to remember that the cost of depression is profound. Beside the mortality associated with suicide and infanticide related to PPD, there is loss of work productivity, as well as childcare safety implications. There are substantial societal implications to not treating the disorder rapidly. I think the question’s going to be, will women accept eight weeks of uncertain therapy (from current anti-depressants not specifically indicated for PPD) that may or may not resolve the issue, especially when there is an available treatment with a high probability of providing a positive outcome in 60 hours? That’s going to be an issue all the payers will have to discuss, with respect to liability and their own ability to restrict access to what may become the only specifically approved treatment of PPD. It requires a different way of thinking. What is it worth to get people better in a few days, versus many weeks, with a definite maybe getting better being thrown in on the latter?