Post by icemandios on May 3, 2021 12:45:51 GMT
Antares Pharma Announces Poster Presentation at the Pediatric Endocrine Society 2021 Virtual Annual Meeting
EWING, N.J., May 03, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced that data highlighting the therapeutic potential of subcutaneous testosterone enanthate in younger hypogonadal populations was presented in a poster presentation at the Pediatric Endocrine Society (PES) 2021 Virtual Annual Meeting on April 30 – May 3, 2021.
The poster presentation entitled, “ Allometric Scaling of Testosterone Enanthate Pharmacokinetics from Adult Males to Adolescent Hypogonadal Males (30-60 kg) After IM and SC Administration Using Population PK Modeling” , was presented by Maria Vogiatzi, MD*, Professor of Pediatrics and Director, Adrenal and Puberty Center, Division of Endocrinology and Diabetes, Children’s Hospital of Philadelphia, Philadelphia, PA. Pharmacokinetic modelling of datasets from the Company’s Phase 2 trial for XYOSTED ® for the treatment of hypogonadism in adult males was performed to permit the extrapolation of testosterone exposure to patients with body weights typical of preadolescent males. The PK modelling showed that subcutaneous testosterone enanthate dosed at a reduced frequency predicted testosterone exposure similar to normal adolescents and could represent a viable treatment option for permanently hypogonadal adolescent males, who require lifelong hormonal support.
Dr. Vogiatzi commented, “We were pleased to be able to share this novel data extrapolation with our colleagues and peers. Although XYOSTED has been FDA-approved for the treatment of testosterone deficiency only in adult males, our analysis of the PK data suggests that it could also potentially be confirmed for use in adolescent hypogonadal males with additional clinical studies. There are currently no approved autoinjectors to deliver subcutaneous testosterone in this medically underserved population. We appreciate the recognition of the Pediatric Endocrine Society that allowed us to present these important findings.”
The poster presentation can be accessed at PES Annual Meeting | Pediatric Endocrine Society (pedsendo.org) .
XYOSTED ® (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Safety and efficacy of XYOSTED ® in males less than 18 years old have not been established. Please see Prescribing Information including important safety information and boxed warning at www.xyosted.com .
* Dr. Maria Vogiatzi is a consultant of Antares Pharma, Inc.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.
EWING, N.J., May 03, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced that data highlighting the therapeutic potential of subcutaneous testosterone enanthate in younger hypogonadal populations was presented in a poster presentation at the Pediatric Endocrine Society (PES) 2021 Virtual Annual Meeting on April 30 – May 3, 2021.
The poster presentation entitled, “ Allometric Scaling of Testosterone Enanthate Pharmacokinetics from Adult Males to Adolescent Hypogonadal Males (30-60 kg) After IM and SC Administration Using Population PK Modeling” , was presented by Maria Vogiatzi, MD*, Professor of Pediatrics and Director, Adrenal and Puberty Center, Division of Endocrinology and Diabetes, Children’s Hospital of Philadelphia, Philadelphia, PA. Pharmacokinetic modelling of datasets from the Company’s Phase 2 trial for XYOSTED ® for the treatment of hypogonadism in adult males was performed to permit the extrapolation of testosterone exposure to patients with body weights typical of preadolescent males. The PK modelling showed that subcutaneous testosterone enanthate dosed at a reduced frequency predicted testosterone exposure similar to normal adolescents and could represent a viable treatment option for permanently hypogonadal adolescent males, who require lifelong hormonal support.
Dr. Vogiatzi commented, “We were pleased to be able to share this novel data extrapolation with our colleagues and peers. Although XYOSTED has been FDA-approved for the treatment of testosterone deficiency only in adult males, our analysis of the PK data suggests that it could also potentially be confirmed for use in adolescent hypogonadal males with additional clinical studies. There are currently no approved autoinjectors to deliver subcutaneous testosterone in this medically underserved population. We appreciate the recognition of the Pediatric Endocrine Society that allowed us to present these important findings.”
The poster presentation can be accessed at PES Annual Meeting | Pediatric Endocrine Society (pedsendo.org) .
XYOSTED ® (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Safety and efficacy of XYOSTED ® in males less than 18 years old have not been established. Please see Prescribing Information including important safety information and boxed warning at www.xyosted.com .
* Dr. Maria Vogiatzi is a consultant of Antares Pharma, Inc.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.
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