Sage Therapeutics has gained clearance from the US Drug Enforcement Administration (DEA) to make its postpartum depression treatment Zulresso available to the first patients.
The drug gained approval from the FDA in March, but needed additional clearance from the DEA because it is a controlled drug, and carries the risk of abuse.
The treatment has been hailed a potential major advance in helping women who suffer postpartum depression (PPD), a condition which can occur during pregnancy or after childbirth, and can be crippling, with some women driven to suicidal thoughts.
Zulresso (brexanolone) is the first treatment specifically approved for the condition, and unlike conventional antidepressants, which can take weeks to take effect, the single infusion starts working within 2-3 days, and can help alleviate some of the condition’s worst symptoms.
The DEA clearance means Zulresso will reach the first patients in late June. It will be administered via continuous intravenous (IV) infusion for 2.5 days under the supervision of healthcare providers in sites of care certified under the Zulresso Risk Evaluation and Mitigation Strategy (REMS) programme.
“Historically, women suffering from PPD may have avoided seeking help because of the stigma, lack of a specifically approved treatment and the complicated journey to care – challenges that have been difficult for women with PPD and their families to overcome,” said Mike Cloonan, chief business officer at Sage.
“Sage is taking on those challenges and creating a family-centric approach to Zulresso availability by enabling pathways to care including building our patient support organisation, where we will provide a range of meaningful support resources to women with PPD and their families to help navigate the Zulresso treatment journey.
The company has to identify and set up ‘centres of excellence’ which can provide a good experience for patients and also follow the REMS programme rules.
These strict controls around its use, and the speed with which patients must be identified to benefit from the treatment means questions have been raised about how many women will receive the treatment.
Zulresso has a US list price of $34,000 per treatment, a high cost which is likely to further limit its use. Analysts predict the drug could reach peak sales of $250m.