LPCN 1154 – Postpartum Depression
Rapid relief
Short treatment duration
Superior tolerability
Product Candidate: LPCN 1154
Rapid-acting, bioidentical neuroactive steroid oral antidepressant
Product Attributes:
LPCN 1154, oral brexanolone (to be marketed as BRLIZIOTM), is chemically identical to the endogenous human hormone allopregnanolone. Brexanolone is a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 1154’s proposed indication is treatment of postpartum depression (PPD).
Higher risk of recurrence, severity, chronicity is common in PPD. PPD is an especially serious condition in women with psychiatric history. LPCN 1154 has the potential for acute stabilization of symptoms in hours, with the freedom of “at home” dosing, while presenting clinically meaningful improved tolerability with minimal label encumbrances.
The 48-hour at home treatment duration offers optionality for convenient dosing of this often-stigmatized indication.
LPCN 1154 could be an appealing option for PPD patients with suicidal ideation and in whom rapid improvement is a priority. LPCN 1154 enables accessibility without compromising the mother–child dyad interactions, with fastest relief and few limitations on daily activities.
About Indication:
Postpartum depression (PPD) is a prevalent and potentially debilitating and life-threatening condition, occurring following ~ 12% of births. Approximately 1 in 8 mothers suffers from PPD in the United States alone; this equates to approximately 500,000 women being affected by PPD annually. PPD impacts the function and quality of life of the patient and can have profound negative effects on the maternal-infant bond and infant development.
PPD is symptomatically indistinguishable from an episode of major depression. However, the timing of its onset has led to its recognition as a distinct illness. As with other forms of depression, PPD is characterized by sadness and/or anhedonia and may present symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.
In the United States, mental health conditions, including suicide, substance use disorders, and unintentional overdose, are the leading causes of pregnancy-related death, particularly after 6 months postpartum.
Traditional antidepressants, not specifically approved for PPD, have slow onset of action, side effects, and may require chronic therapy, and do not demonstrate adequate remission post-acute treatment. Drugs approved for major depressive disorder (MDD) and non-pharmacological treatments are commonly used to treat PPD, but efficacy data are sparse.
There is currently only one approved option for the treatment of PPD in adults, a synthetic neuroactive steroid structurally based on pregnanolone, an isomer of allopregnanolone, which is taken for 14 days. In clinical trials, side effects such as somnolence, dizziness, and fatigue are common, and in some cases resulted in discontinuation of therapy.
A well-tolerated, easily accessible, outpatient, rapid-acting PPD treatment with persistent efficacy is critically important for the safety, function, and well-being of the mother, child, and family.