November 02, 2018 04:15 PM Eastern Daylight Time
TORRANCE, Callif.--(BUSINESS WIRE)--Emmaus Life Sciences, Inc. (Emmaus), a leader in sickle cell disease treatment, announced today that its abstract has been accepted for poster presentation at the American Society of Hematology (ASH) 2018 Annual Meeting taking place in San Diego, California from December 1 - 4.
The abstract highlights aspects of its Phase 3 study of Endari™ (L-glutamine oral powder). Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal back pain, and chest pain.
The ASH abstract is available at: https://ash.confex.com/ash/2018/webprogram/Paper119720.html.
Details of the poster presentation:
Session #113: Hemoglobinopathies, Excluding Thalassemia—Basic and Translational Science: Poster I
Abstract 1065: Consistent Benefit of L-glutamine Observed across Patients with Low, Medium, and High Number of Crises Reported in the Year Prior to Screening – Analysis from the Phase 3 Study of L-glutamine in Sickle Cell Anemia
Time: Saturday, Dec. 1, 2018, 6:15 PM-8:15 PM PT
Location: Hall GH (San Diego Convention Center)
Dr. Niihara, the CEO and founder of Emmaus, commented: “We look forward to this opportunity to deliver additional information from our Phase 3 trial to practitioners. The ASH abstract shows consistent benefit to those patients in the Endari treatment arm, irrespective of their history of sickle cell crises prior to their participation in the trial.”
Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.
Important Safety Information
The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.
The safety and efficacy of Endari in pediatric patients with sickle cell disease younger than five years of age has not been established.
For more information, please see full Prescribing Information of Endari at: www.ENDARIrx.com/PI.
About Emmaus Life Sciences, Inc.
Emmaus Life Sciences, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of innovative treatments and therapies primarily for rare and orphan disease. Its lead product, Endari, demonstrated positive clinical results in the completed Phase 3 clinical trial for sickle cell anemia and sickle ß0-thalassemia and has received U.S. FDA approval. Visit: http://www.emmausmedical.com.
Forward-Looking StatementsThis press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and potential commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Additional risks and uncertainties are described in reports filed by Emmaus Life Sciences, Inc. with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Emmaus is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
LaVoie Health Science
Katie Gallagher, 617-374-8800 x109