8 July 2019 - - US-based Sage Therapeutics has launched Zulresso (brexanolone) injection, which was approved by the US Food and Drug Administration on March 19, 2019, and is the first and only treatment specifically approved for postpartum depression, one of the most common medical complications during and after pregnancy, US-based Ligand Pharmaceuticals Inc. (NASDAQ: LGND) said.
Zulresso uses Ligand's Captisol in its formulation.
With this launch, Zulresso is the 11th FDA-approved drug to use Ligand's patented Captisol technology.
Zulresso is administered via continuous intravenous infusion for 2.5 days under the supervision of healthcare providers in sites of care certified under the Zulresso Risk Evaluation and Mitigation Strategy programme.
Postpartum depression is one of the most common medical complications during and after pregnancy. PPD is a distinct and readily identified major depressive episode that can occur during pregnancy or after giving birth.
Expert opinions vary as to the timing of the onset of PPD, ranging from onset during pregnancy up to 4-weeks postpartum and onset during pregnancy up to 12-months postpartum.
PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem.
PPD can be a life-threatening condition due to the risk of suicide, a leading cause of maternal death following childbirth. PPD is estimated to affect approximately one in nine women who have given birth in the US and 400,000 women annually.
More than half of these cases may go undiagnosed without proper screening.
Zulresso, the first medicine specifically approved by the US Food and Drug Administration for the treatment of postpartum depression in adults, is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors.
Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.
Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas' Higuchi Biosciences Center, for specific use in drug development and formulation.
This unique technology has enabled several FDA-approved products, including Amgen's Kyprolis, Baxter International's Nexterone, Acrotech Biopharma's EVOMELA, Melinta Therapeutics' Baxdela, Sage Therapeutics' Zulresso, Merck and Co.'s Noxafil and Pfizer's Vfend.
There are many Captisol-enabled products currently in various stages of development.
Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines.