Ready to enroll in the PAX-101 REMS Program?
Exclusive Distributor of PaxMedica Products in Development for
Autism Spectrum Disorder
PaxMedica is a clinical-stage biopharmaceutical company focused on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms.
PaxMedica’s lead product is PAX-101 (intravenous suramin). The company is first seeking approval under the FDA’s orphan drug program for the treatment of Stage 1 African Sleeping Sickness (also known as Human African Trypanosomiasis Brucei Rhodesiense or TBR HAT). This is an interim step expected to speed the path to FDA consideration of PAX-101 for ASD.
PAX-101 has shown promising results in moderating the challenging core symptoms of ASD in children (median age 8.34 years) in a phase 2 trial.
Details of that study have been published in the Annals of General Psychiatry (Nov. 6, 2023), available here.
Enroll in PAXREMS:
The PAX-101 Risk Evaluation and Mitigation Strategy Program
As PaxMedica progresses in its development program for PAX-101 for ASD, VoxNova may have a limited supply in 2024 to be made available through expanded access.
We expect that PAX-101 will be available in very limited quantities and that demand likely will exceed supply. We encourage physicians with an interest in prescribing intravenous suramin to apply now for enrollment in the PAX-101 Risk Evaluation and Mitigation Strategy Program (PAXREMS), administered by VoxNova. Safeguards and precautions to ensure appropriate use of the drug will be rigorously followed.
Physicians authorized through the PAXREMS must meet several requirements:
- Have access to an infusion center
- Have treatments available to calm applicable patients during the 30-60 minute infusion
- Provide patient-specific information on treatment outcomes on a regular basis as required by PAXREMS
If you treat children with ASD and wish to be considered for participation in expanded access, we encourage you to enroll in PAXREMS now.
PAX-101 Risk Evaluation
and Mitigation Strategy Program
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