Mental Health,
Women,
FDA,
Baby,
Maternity,
Clinical Trials,
Biotechnology,
Health,
Consumer,
Pharmaceutical,
American College,
Regulation,
PPD,
Woman,
Behavioral activation,
Food,
Cognitive behavioral therapy,
BAT,
Depression,
DBT,
Smartphone,
Summer,
ACOG,
Therapy,
Edinburgh Postnatal Depression Scale,
Patient,
MPH,
Postpartum depression,
Face,
ITT,
IPT,
RCT,
Dialectical behavior therapy,
CBT,
EPDS Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
Key Points:
- Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
- MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.
- MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for postpartum depression.
- The clearance of MamaLift Plus is based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER).
Retrieved on:
Monday, September 18, 2023
PPD,
Pregnancy,
Reunion,
Female,
Death,
Patient,
Risk,
Child,
Heel,
FDA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Mental health,
IND,
Food,
Safety,
Pharmaceutical industry,
Nursing The Phase 2 study, the RECONNECT Trial, is a multicenter, randomized, double-blind, parallel-group, active-dose placebo-controlled study, which will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with PPD.
Key Points:
- The Phase 2 study, the RECONNECT Trial, is a multicenter, randomized, double-blind, parallel-group, active-dose placebo-controlled study, which will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with PPD.
- The study is expected to begin in Q4 2023 with a targeted data readout in late 2024.
- “Mental health conditions unfortunately remain the leading cause of pregnancy related deaths.
- Reunion is committed to making a significant difference in improving outcomes in this patient population and other mental health disorders.”
Retrieved on:
Tuesday, February 14, 2023
Mental Health,
Research,
FDA,
Clinical Trials,
Biotechnology,
Health,
Pharmaceutical,
General Health,
Science,
Allopregnanolone,
LSE,
Social anxiety,
Woman,
Therapy,
Village development committee (Nepal),
PPD,
PureTech Health,
Patient,
Clinical trial,
Depression,
Anxiety,
PRTC,
GABAA,
Multimedia,
R,
Pharmaceutical industry,
Vaccine,
Glyph PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, today announced that it will advance LYT-300 (oral allopregnanolone) for the potential treatment of anxiety disorders and postpartum depression (PPD).
Key Points:
- PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, today announced that it will advance LYT-300 (oral allopregnanolone) for the potential treatment of anxiety disorders and postpartum depression (PPD).
- An open-label, Phase 2a, proof-of-concept clinical trial in women with PPD is expected to initiate in the second half of 2023.
- “Using our proprietary Glyph™ platform, we have made natural allopregnanolone orally bioavailable without permanently chemically modifying the natural neurosteroid.
- It has demonstrated a rapid onset of action for the treatment of depression, as well as the potential to treat other neurological conditions, including anxiety, but its poor oral bioavailability has limited its therapeutic potential.
Science,
Biotechnology,
Research,
Pharmaceutical,
General Health,
Health,
FDA,
Mental Health,
Woman,
BIIB,
NDA,
Physician,
Disability,
PPD,
DSM-IV codes,
Diagnosis,
Development,
PDUFA,
Safety,
Postpartum depression,
Priority review,
Biogen,
Patient,
Shionogi,
Depression,
NEST,
Food,
Behavior,
CORAL,
Arousal,
Therapy,
Regulatory science,
MDD,
Multimedia,
Regulation of tobacco by the U.S. Food and Drug Administration,
Quality of life,
Zuranolone,
Cognition,
Pharmaceutical industry,
Medical device,
Sage Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Key Points:
- Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
- Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD.
- The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.
- In people with depression, it is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function.
Food,
Diagnosis,
Safety,
Biogen,
PDUFA,
Regulatory science,
MDD,
Cognition,
Behavior,
Quality of life,
Postpartum depression,
Shionogi,
Disability,
NDA,
Physician,
Depression,
Patient,
Arousal,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
FDA,
BIIB,
Development,
Woman,
PPD,
NEST,
Sage,
Priority review,
CORAL,
Pharmaceutical industry,
Medical device,
Zuranolone Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD.
Key Points:
- Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD.
- The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.
- The LANDSCAPE program includes five studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL).
- In people with depression, it is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function.
Biotechnology,
Baby,
Maternity,
Other Health,
General Health,
Health,
Women,
Pharmaceutical,
Consumer,
RTT,
Depression,
Health,
Psychiatric diagnosis,
Women,
Motherhood,
Human reproduction,
Midwifery,
Postpartum depression,
Pregnancy,
Postpartum period,
Major depressive disorder,
Postpartum Depression,
ZULRESSO™ (brexanolone) injection,
Captisol®,
Ligand Pharmaceuticals With this launch, ZULRESSO is the 11th FDA-approved drug to use Ligands patented Captisol technology.
Key Points:
- With this launch, ZULRESSO is the 11th FDA-approved drug to use Ligands patented Captisol technology.
- For more information on ZULRESSO, including the final product label, visit ZULRESSO.COM or ZULRESSOREMS.COM.
- 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.
