Postpartum Depression – LPCN 1154
Postpartum Depression – LPCN 1154
Product Candidate: LPCN 1154
Bioidentical oral antidepressant with the fastest time to action.
Product Attributes:
LPCN 1154, oral Brexanolone (to be marketed as Brlizio), is chemically identical to the endogenous human hormone allopregnanolone. The concentration of allopregnanolone, an endogenous derivative of progesterone, increases during pregnancy, reaches a peak during the third trimester, then abruptly falls after delivery. Brexanolone is a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor LPCN 1154’s proposed indication is treatment of postpartum depression (PPD).
Convenient oral LPCN 1154 has potential for the fastest time to action through its fast-acting mechanism promoting acute stabilization of symptoms in hours with freedom of “at home” dosing while presenting no significant risk of adverse reactions to breastfed infants from exposure to bioidentical brexanolone.
LPCN 1154 is an appealing option for moderate or severe PPD with suicidal ideation and in whom rapid improvement is a priority. LPCN 1154 enables accessibility without compromising the freedom mom – child dyad interaction with fastest relief and fewer limitations in daily activities. LPCN 1154 specifically for treatment of PPD may also be effective at reducing suicidal ideation, particularly among women who experience rapid-onset suicidality following childbirth since the perinatal transition seems to be distinctly high-risk for rapid onset of suicidal thoughts and behaviors.
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 is symptomatically indistinguishable from an episode of major depression. However, the timing of its onset has led to its recognition as a distinct illness. During pregnancy, levels of endogenous NASs increase considerably along with levels of progesterone; however, they drop sharply postpartum. It has been hypothesized that the rapid perinatal decrease in circulating levels of endogenous NASs may be involved in the development of PPD. 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. PPD is highly comorbid with postpartum suicidality. In the United States, suicide is one of the leading causes of death in the first year postpartum, possibly accounting for up to 20% of deaths. 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.
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.
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.
Medications developed specifically for the treatment of PPD may also need to be effective at reducing suicidal ideation, particularly among women who experience rapid-onset suicidality following childbirth. Maternal suicide deaths can have far-reaching consequences for child development, family functioning, and the nation’s economy.
Maternal mental health intervention needs to advance health care practitioners’ decision-making to provide high-quality, effective treatment for this high-risk, appealing option for moderate or severe PPD with suicidal ideation.
Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. 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.