PATH welcomes groundbreaking regulatory approval for contraceptive self-injection

Today, PATH welcomes a regulatory milestone that has the potential to expand access to family planning and increase women's control over their health.

The United Kingdom's lead regulatory agency, the Medicines & Healthcare products Regulatory Agency (MHRA), has authorized self-injection of Pfizer's subcutaneous injectable contraceptive, Sayana® Press, in that country. This update to the Sayana Press label adds the option for self-injection when considered appropriate by a health care professional, making it the first injectable contraceptive in the United Kingdom available for self-administration. Sayana Press is a lower-dose formulation and presentation of the three-month injectable contraceptive Depo-Provera®.

Sayana Press is packaged in the Uniject™ injection system, combining one dose of the contraceptive and a single-use needle in one device. PATH first developed the BD Uniject™ injection system in the 1980s to make injections simpler and safer in low-resource settings. The streamlined design of Sayana Press makes it easier for trained community health workers, and women themselves, to safely provide injections in community locations or homes.

Pfizer's announcement today includes plans to seek regulatory approval of the updated Sayana Press label in a number of additional countries with unmet need and demand for injectable contraception, such as Burkina Faso, Uganda, and Senegal.

In addition to this first approval by the UK's regulatory agency, evidence about self-injection in low-income countries will also be critical for family planning decision-makers considering adoption of the practice. Today's announcement occurs as PATH and ministries of health in Senegal and Uganda are conducting research studies to assess the feasibility and impact of self-injection with Sayana Press. The PATH-MOH Uganda feasibility study launched in June 2015, and nearly all 381 women who elected to self-inject in the study were able to do so immediately following a brief training. A similar study in Senegal will launch in October.

Ms. Allen Namagembe, PATH Sayana Press research coordinator in Uganda, reacts to today's decision: "PATH staff in Uganda are encouraged by the decision of the UK MHRA and excited about the potential benefits of contraceptive self-injection for women in low-resource settings."

Namagembe went on to add, "Many women in my country and other countries in the region walk very far distances and endure long wait times to get family planning services, including injections, so the possibility of a self-injectable contraceptive represents a huge leap forward in terms of access. We are proud to be working with Uganda's Ministry of Health to expand the evidence base through the first self-injection research study in sub-Saharan Africa."

The ongoing PATH-MOH studies, funded by the Bill & Melinda Gates Foundation and The Children's Investment Fund Foundation (CIFF), are collecting information regarding how to support women in settings like Senegal and Uganda to self-inject Sayana Press independently, safely, and effectively.

The PATH-MOH self-injection research studies also build on the momentum of an ongoing Sayana Press pilot introduction program coordinated by PATH, which includes four countries in sub-Saharan Africa: Burkina Faso, Niger, Senegal, and Uganda. PATH is working side-by-side with ministries of health and local partners on these country-led introductions. Between June 2014 and June 2015, approximately 170,600 doses of Sayana Press have been administered to women by providers through family planning programs in the four countries.

In order for women worldwide to access self-injection, country governments will now need to determine whether and how to integrate Sayana Press self-injection into their family planning policy and practice. In countries like the four pilot introduction countries where Sayana Press is already registered, regulatory updates reflecting the self-injection label change will also be needed.

PATH and MOH partners will continue to collect and disseminate evidence on self-injection and Sayana Press use more broadly to inform policy or practice changes. Results on the feasibility of self-injection in Uganda and Senegal will be available in 2016. Starting in mid-2016, further PATH studies with MOH partners will assess whether women who self-inject Sayana Press continue using injectable contraception longer than women who receive traditional intramuscular contraceptive injections administered by providers.

Sayana Press and Depo-Provera are registered trademarks of Pfizer Inc. Uniject is a trademark of BD.

Posted September 23, 2015.