LPCN 1154 – Postpartum Depression
Rapid relief
Short treatment duration
Clinically meaningful improved tolerability
Product Candidate: LPCN 1154
Rapid-acting bioidentical oral antidepressant
Product Attributes:
LPCN 1154, oral Brexanolone (to be marketed as Brlizio), 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).
PPD is highly comorbid with postpartum suicidality. Potential for acute stabilization of symptoms in hours with freedom of “at home” dosing while presenting clinically meaningful improved tolerability with less label encumbrances.
48 hour at home treatment duration offers optionality for discrete 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 freedom of mother – child dyad interaction with fastest relief and fewer limitations in 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 later 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 approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission post-acute treatment. Drugs approved for MDD and non-pharmacological treatments are commonly used to treat PPD, but efficacy data are sparse.
A synthetic neuroactive steroid derivative, zuranolone (ZURZUVAE®), only approved option for the treatment of PPD in adults. ZURZUVAE® is a synthetic neuroactive steroid structurally based on pregnanolone, an isomer of allopregnanolone, and is taken orally once every evening for 14 days.
The most reported AEs (>5%) during clinical trials of zuranolone were somnolence (31%), dizziness (12%), diarrhea (6%), and fatigue (6%). In Clinical studies, adverse events led to discontinuation of ZURZUVAE® ranged from 1-4% of participants; the most common adverse reaction leading to discontinuation was somnolence. Dose reductions due to adverse reaction occurrence ranged from 4- 14% of zuranolone-treated patients, the most common causes were somnolence and dizziness.
An easily accessible outpatient rapid-acting PPD treatment option with persistent efficacy and acceptable tolerability to maintain daily activities is critically important for the safety and well-being of the mother, child, and the family.