Glucocorticoids

Flexion Therapeutics Reports Second-Quarter 2021 Financial Results and Recent Business Highlights

Retrieved on:

Wednesday, August 4, 2021

Steroids, Chemical compounds, Chemistry, Flexion Therapeutics, Acetonides, Diketones, Glucocorticoids, Pregnanes, Triamcinolone acetonide

ZILRETTA (triamcinolone acetonide extended-release injectable suspension) net sales were $28.2million in Q2 2021, reflecting growth of 15% over the previous quarter

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ZILRETTA (triamcinolone acetonide extended-release injectable suspension) net sales were $28.2million in Q2 2021, reflecting growth of 15% over the previous quarter
Net loss in Q2 2021 decreased by $10.4million (32%), as compared to Q2 2020, during the height of the COVID-19 impact on ZILRETTA sales
BURLINGTON, Mass., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial results and recent business highlights for the quarter ended June30, 2021.
Net sales of ZILRETTA were $28.2million and $15.5million for the three months ended June30, 2021 and 2020, respectively.
Loss per share for the second quarter of 2021 was $0.44, compared to $0.76 for the same period of 2020.
Research and development expenses were $12.7million and $12.5million for the three months ended June30, 2021 and 2020, respectively.

Antares Pharma Announces FDA Acceptance of IND Application for ATRS-1902 for Adrenal Crisis Rescue

Retrieved on:

Thursday, July 22, 2021

Health sciences, Health care, Health, Food and Drug Administration, Glucocorticoids, Drug Safety, Corticosteroids, Alcohols, Hydrocortisone, New Drug Application, Investigational New Drug, Pharmaceutical industry

EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.

Key Points:

EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.
The FDA acceptance of this IND is an important milestone in the development of a novel formulation and delivery of hydrocortisone in a crisis situation.
Current standard of care for the management of acute adrenal crises includes Solu-Cortef, which is an anti-inflammatory glucocorticoid.
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, We are pleased to be able to advance the development of our proprietary pipeline with the FDA acceptance of this IND.

Scilex Holding Company, a Sorrento Company, Announces Complete Enrollment on Non-Opioid Injectable SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program For Sciatica Pain Management

Retrieved on:

Tuesday, July 20, 2021

Organ systems, Branches of biology, Nervous system, Pain, Glucocorticoids, COVID-19, COVID-19 drug development, Dexamethasone, Otologicals, Radicular pain, Sciatica, Sciatic nerve

Scilex Holding Company, a commercial-stage, non-opioid biopharmaceutical pain management company, announced complete enrollment of its SP-102 (SEMDEXA) Phase 3 Pivotal Trial C.L.E.A.R.

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Scilex Holding Company, a commercial-stage, non-opioid biopharmaceutical pain management company, announced complete enrollment of its SP-102 (SEMDEXA) Phase 3 Pivotal Trial C.L.E.A.R.
Program for its novel, non-opioid, corticosteroid formulation, injectable dexamethasone sodium phosphate viscous gel product for the treatment of lumbosacral radicular pain (sciatica).
Program, a corticosteroid injectable dexamethasone sodium phosphate gel for the treatment of lumbosacral radicular pain, or sciatica.
Scilexs SP-102 (SEMDEXA) is currently being evaluated in a pivotal Phase 3 clinical trial in the U.S. in patients with lumbosacral radicular pain (sciatica).

EPI Health and MC2 Therapeutics announces U.S. Launch of Wynzora® Cream for Plaque Psoriasis (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%)

Retrieved on:

Monday, July 19, 2021

Drugs, Steroids, Organ systems, Corticosteroids, Combination drugs, Antipsoriatics, Glucocorticoids, Calcipotriol/betamethasone dipropionate, Betamethasone dipropionate, Betamethasone, Psoriasis, Calcipotriol

"Calcipotriene and betamethasone dipropionate are well-established molecules for the treatment ofplaque psoriasis, with proven efficacy, safety and tolerability.

Key Points:

"Calcipotriene and betamethasone dipropionate are well-established molecules for the treatment ofplaque psoriasis, with proven efficacy, safety and tolerability.
Until now they could not be combinedinto an aqueous cream, which is less greasy and more user-friendly than other formulations."
Wynzora Cream is based on PADTechnology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in aconvenient-to-use aqueous formulation.
Wynzora (calcipotriene and betamethasone dipropionate) Cream is indicated for plaque psoriasis inadults.It is notknown ifWynzoraCream is safeand effectivein children.

Glycomine’s Natural History Study Informs Potentially Lifesaving Update to Standard of Care for PMM2-CDG Patients

Retrieved on:

Tuesday, June 29, 2021

These data provide key insights to improve standard of care, as early recognition of adrenal insufficiency and initiation of glucocorticoid replacement therapy and stress dosing could be lifesaving.

Key Points:

These data provide key insights to improve standard of care, as early recognition of adrenal insufficiency and initiation of glucocorticoid replacement therapy and stress dosing could be lifesaving.
The authors conclude that morning cortisol and ACTH levels should be evaluated at least annually for all patients with PMM2-CDG.
Through an international collaboration, this study was the first to identify that patients with PMM2-CDG are at risk for secondary adrenal insufficiency and to suggest that morning cortisol and ACTH monitoring should become part of standard care in these patients.
The natural history study completed enrollment with 139 PMM2-CDG patients at 11 sites around the world (ClinicalTrials.gov Identifier: NCT03173300 ).

Santhera and ReveraGen to Present Findings from Pivotal VISION-DMD Study with Vamorolone at Parent Project Muscular Dystrophy 2021 Conference

Retrieved on:

Thursday, June 24, 2021

Glucocorticoids, Organ systems, Medicine, Medical specialties, Prodrugs, Pregnanes, Muscular dystrophy, Diols, Vamorolone, Prednisone, Dystrophy, Duchenne

The study also demonstrated superiority of both vamorolone dose levels (2 and 6mg/kg/day) versus placebo across multiple secondary endpoints.

Key Points:

The study also demonstrated superiority of both vamorolone dose levels (2 and 6mg/kg/day) versus placebo across multiple secondary endpoints.
Vamorolone did not stunt growth, as validated in the current 24-week study, in which vamorolone 6mg/kg/day versus prednisone 0.75mg/kg/day showed a significant difference in growth velocity (p=0.02).
The primary endpoint of the study is TTSTAND velocity at 24 weeks comparing the 6mg/kg/day dose of vamorolone to placebo.
ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

Eton Pharmaceuticals Acquires U.S. and Canadian Rights to ZENEO® Hydrocortisone Autoinjector

Retrieved on:

Tuesday, June 15, 2021

Steroids, Drugs, Adrenal gland disorders, Organ systems, Glucocorticoids, Antipruritics, Hydrocortisone, Ketones, Mineralocorticoids, Autoinjector, Adrenal insufficiency

The ZENEO autoinjector is a revolutionary delivery system, and this product is a terrific strategic fit with our current adrenal insufficiency business.

Key Points:

The ZENEO autoinjector is a revolutionary delivery system, and this product is a terrific strategic fit with our current adrenal insufficiency business.
ETON has successfully established strong relations with the patient communities and medical specialists that are its core focus.
ZENEO hydrocortisone is expected to be the first and only hydrocortisone autoinjector available for patients that require a rescue dose of hydrocortisone.
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.

Corcept Therapeutics Appoints Joshua M. Murray to Board of Directors

Retrieved on:

Thursday, June 10, 2021

Corcept Therapeutics, Anxiety, Glucocorticoids, Cortisol, Cort, Health care

MENLO PARK, Calif., June 10, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that Joshua M. Murray has joined the companys Board of Directors.

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MENLO PARK, Calif., June 10, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that Joshua M. Murray has joined the companys Board of Directors.
Mr. Murray is currently Senior Vice President, Finance, Strategy and Investor Relations at Orca Bio, a privately held biotechnology company developing allogeneic cell therapies in blood, immune, and genetic diseases.
I am very pleased to welcome Josh to our board, said Joseph K. Belanoff, MD, Corcepts Chief Executive Officer.
Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol.

Sparrow Pharmaceuticals Presents Data on SPI-62 at the European Congress of Endocrinology

Retrieved on:

Saturday, May 22, 2021

Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Steroids, Endocrine system, Glucocorticoids, Organ systems, Corticosteroids, Anxiety, Cortisol, Otologicals, Pregnanes

Sparrow\xe2\x80\x99s novel approach to treatment of CS is based on recognition that the predominant source of intracellular cortisol is HSD-1.

Key Points:

Sparrow\xe2\x80\x99s novel approach to treatment of CS is based on recognition that the predominant source of intracellular cortisol is HSD-1.
That\xe2\x80\x99s formed mostly by HSD-1,\xe2\x80\x9d said Dr. David Katz, Chief Scientific Officer of Sparrow.
\xe2\x80\x9cSPI-62 can reduce that pool by up to 90% and was associated with favorable clinical changes in patients with diabetes.
Its lead product, SPI-62, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular corticosteroids in key tissues.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210522005003/en/\n'

Veru Enrolls First Patient in Phase 3 Clinical Trial of Sabizabulin (VERU-111) in High Risk Hospitalized COVID-19 Patients

Retrieved on:

Wednesday, May 19, 2021

Drugs, Medical specialties, Clinical medicine, Glucocorticoids, Progestogens, Acute respiratory distress syndrome, Intensive care medicine, Respiratory physiology, Bioavailability, Medroxyprogesterone acetate

Because of better oral bioavailability, the systemic blood levels from the 9mg sabizabulin dosage are similar to the 18mg sabizabulin formulation used in the Phase 2 clinical study.

Key Points:

Because of better oral bioavailability, the systemic blood levels from the 9mg sabizabulin dosage are similar to the 18mg sabizabulin formulation used in the Phase 2 clinical study.
The primary efficacy endpoint will be the proportion of patients that die on study up to Day 60.
Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled.
The Company disclaims any intent or obligation to update these forward-looking statements.\nPhase 3 Clinical Trial Contact:\n'