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WILMINGTON, Del: NRx Pharmaceuticals, Inc. has issued the following news release: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ('NRx', the 'Company'), a clinical-stage biopharmaceutical company, today announced the transmission of first section [...]

Company to initiate Phase 2 trial of ABX-002 for bipolar depression by yearend 2024 ABX-002 also being evaluated as an adjunctive treatment for major depressive disorder in the ongoing AMPLIFY [...]

* Harvard University Associate Professor, Dr. Ovidiu Andronesi MD, PhD, will be the principal investigator of the study * Head-to-head study of AL001 versus a marketed lithium carbonate product will [...]

* Harvard University Associate Professor, Dr. Ovidiu Andronesi MD, PhD, will be the principal investigator of the study * Head-to-head study of AL001 versus a marketed lithium carbonate product will [...]

RADNOR, Pa: NRx Pharmaceuticals, Inc has issued the following press release: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ('NRx Pharmaceuticals', the 'Company'), a clinical-stage biopharmaceutical company, today announced that advice from regulatory [...]

WASHINGTON: Vanda Pharmaceuticals Inc. has issued the following news release: Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt(r) (iloperidone) [...]

Fanapt Treatment is Now Available to Adult Patients for the Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder Approval Represents Significant Novel Indication for Vanda's Fanapt [...]

WASHINGTON: Vanda Pharmaceuticals Inc. has issued the following news release: Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled 'Efficacy and Safety of Iloperidone in [...]

WASHINGTON, Jan. 17, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled 'Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, [...]

* Alzamend's recently completed Phase IIA study of AL001 in Alzheimer's patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require [...]

ATLANTA: Alzamend Neuro, Inc. (Alzamend), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease (Alzheimer's), bipolar disorder, major depressive disorder and post-traumatic stress disorder, [...]

* Alzamend's recently completed Phase IIA study of AL001 in Alzheimer's patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require [...]

ATLANTA: Alzamend Neuro, Inc. has issued the following news release: Alzamend Neuro, Inc. (Nasdaq: ALZN) ('Alzamend'), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's [...]

* Alzamend's recently completed Phase IIA Study of AL001 in Alzheimer's patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require [...]

2024 APR 15 (NewsRx) -- By a News Reporter-Staff News Editor at Mental Health Weekly Digest -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug [...]

ATLANTA: Alzamend Neuro, Inc., a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease bipolar disorder ('BD'), major depressive disorder ('MDD') and post-traumatic stress disorder [...]

* Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval * Alzamend recently completed a Phase IIA Study of AL001 in Alzheimer's patients and [...]

ATLANTA: Alzamend Neuro, Inc., ('Alzamend') a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease ('Alzheimer's'), bipolar disorder ('BD'), major depressive disorder ('MDD') and post-traumatic [...]

* Alzamend's recently completed Phase IIA study of AL001 in Alzheimer's patients and healthy subjects identified a candidate dose that is unlikely to require therapeutic drug monitoring * Safety aspects [...]

Alzamend Neuro, a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease, bipolar disorder (BD), major depressive disorder (MDD) and post-traumatic stress disorder (PTSD), reported [...]

PRINCETON: Otsuka America Pharmaceutical, Inc., and Lundbeck have announced the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ABILIFY ASIMTUFII(r) (aripiprazole) extended-release injectable suspension [...]

PRINCETON, N.J. & DEERFIELD, Ill. -- Otsuka America Pharmaceutical, Inc. (Otsuka) and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ABILIFY [...]

Rykindo is a bi-weekly long-acting risperidone injection and is the first innovative therapy from Luye Pharma's Central Nervous System (CNS) product portfolio to be marketed in the United States. PRINCETON, [...]

Approval marks fourth indication for VRAYLAR, backed by proven efficacy and well-established tolerability as an adjunctive treatment for major depressive disorder (MDD) with an antidepressant therapy (ADT), showing improvement in [...]

On 19 Dec 2022, Richter Gedeon's partner AbbVie announced that the US Food and Drug Administration (FDA) has approved VRAYLAR (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant. Cariprazine is marketed as VRAYLAR in the US, and in addition to being approved as an adjunctive therapy to antidepressants for the treatment of MDD in adults, it is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. Cariprazine is co-developed by AbbVie and Gedeon Richter Plc. A Phase 3 Study 3111-301-001 showed a clinically and statistically significant change from baseline to week six in the Montgomery-Asberg Depression Rating Scale (MADRS) total score for patients treated with cariprazine at 1.5 mg/day + ADT compared with placebo + ADT. A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the MADRS total score for patients treated with cariprazine at 2-4.5 mg/d (mean dose 2.6 mg) + ADT compared with placebo + ADT. Cariprazine was generally well-tolerated in 6- and 8-week studies. Mean weight change was below 2lbs and less than or equal to 3% of patients had a weight increase of greater than or equal to 7%. The starting dosage of VRAYLAR is 1.5 mg once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg once daily on Day 15. In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. The maximum recommended dosage is 3 mg, once daily. Most common adverse reactions observed in the adjunctive MDD studies (greater than or equal to 5% and at least twice the rate of placebo) were: akathisia, nausea, and insomnia at the recommended doses in 6-week, fixed-dose trials; and akathisia, restlessness, fatigue, constipation, nausea, increased appetite, dizziness, insomnia, and extrapyramidal symptoms in one 8-week flexible-dose trial at a titration of less than 14 days. Original source: Gedeon Richter, website: http://www.richter.hu/EN/, Copyright Gedeon Richter plc 2022., joint venture; regulations and rulings; research and development; cariprazine; VRAYLAR; AbbVie; Richter [...]

AbbVie announced on 16 Dec 2022 that the US Food and Drug Administration (FDA) has approved VRAYLAR (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant. Cariprazine is marketed as VRAYLAR in the US, and in addition to being approved as an adjunctive therapy to antidepressants for the treatment of MDD in adults, it is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. Cariprazine is co-developed by AbbVie and Gedeon Richter Plc. More than 8000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy and safety of cariprazine for a broad range of psychiatric disorders. Highlights from the clinical program supporting the approval include: A Phase 3 Study 3111-301-001 showed a clinically and statistically significant change from baseline to week six in the Montgomery-Asberg Depression Rating Scale (MADRS) total score for patients treated with cariprazine at 1.5 mg/day + ADT compared with placebo + ADT. A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the MADRS total score for patients treated with cariprazine at 2-4.5 mg/day (mean dose 2.6 mg) + ADT compared with placebo + ADT. Cariprazine was generally well tolerated in 6- and 8-week studies. Mean weight change was less than 2lbs and at most 3% of patients had a weight increase of at least 7%. The starting dosage of VRAYLAR is 1.5 mg once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg once daily on Day 15. In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. The maximum recommended dosage is 3 mg once daily. Most common adverse reactions observed in the adjunctive MDD studies (at least 5% and at least twice the rate of placebo) were: Akathisia, nausea, and insomnia at the recommended doses in 6-week, fixed-dose trials. Akathisia, restlessness, fatigue, constipation, nausea, increased appetite, dizziness, insomnia, and extrapyramidal symptoms in one 8-week flexible-dose trial at a titration of less than 14 days. Original source: Abbvie, website: https://www.abbvie.com/, Copyright Abbvie Inc. 2022., joint venture; regulations and rulings; research and development; cariprazine; VRAYLAR; AbbVie; Gedeon [...]

- Approval marks fourth indication for VRAYLAR, backed by proven efficacy and well-established tolerability as an adjunctive treatment for major depressive disorder (MDD) with an antidepressant therapy (ADT), showing improvement [...]

Manufacturing files submitted to U.S. Food and Drug Administration The company has now completed its transition to U.S.-based manufacturing NRX-101 is now manufactured via a commercial-stage process RADNOR, Pa., Nov. [...]

PRINCETON: OTSUKA AMERICA PHARMACEUTICAL, INC. has issued the following news release: Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance [...]

Tokyo: Otsuka Holdings Co.,Ltd. has issued the following news release: Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance of [...]

* If approved, aripiprazole 2-month ready-to-use (RTU), long-acting injectable (LAI) would be the first 2-month, LAI antipsychotic indicated for both treatment of schizophrenia and the maintenance treatment of bipolar I [...]

M2 EQUITYBITES-April 28, 2023-Otsuka and Lundbeck's ABILIFY ASIMTUFII receives FDA approval for treatment of schizophrenia and bipolar I disorder (C)2023 M2 COMMUNICATIONS http://www.m2.co.uk Danish pharmaceutical company H. Lundbeck A/S (CPH:HLUN-A) [...]