Clinical-stage pharmaceutical firm Cempra has secured orphan drug status from the US Food and Drug Administration (FDA) for its drug candidate Taksta (CEM-102) to treat patients with prosthetic joint infections (PJI).

The orphan drug status will help in accelerating the development of drugs that would offer significant benefit to patients suffering from rare diseases.

Cempra’s Taksta, an oral loading dose formulation of fusidic acid, is an orally active anti-staphylococcal agent that has a long history of safety and efficacy outside of the US.

Cempra chief executive officer Prabhavathi Fernandes said: “Treatment of PJIs is a poorly met need in the US that usually requires joint debridement and weeks to months of intravenous administration of antibiotics.

“Treatment of PJIs is a poorly met need in the US that usually requires joint debridement and weeks to months of intravenous administration of antibiotics.”

“If the antibiotic regimen fails then patients usually undergo an onerous multistep process of continued intravenous antibiotics, joint removal, replacement with a temporary spacer then re-implantation of a new joint following confirmation that the infection has cleared.”

If approved, Taksta is expected to reduce procedure-related morbidity in patients and improve patient quality of life by replacing the existing treatment with a twice-daily oral pill.

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At present, the treatment is available in several countries including the UK, where oral fusidic acid is available.

In the US, patients with PJIs are currently treated with intravenous antibiotics like vancomycin, an oral drug that can be safely administered for a long period of time as well as improve care and quality of life for these patients.

Image: Numerous clumps of methicillin-resistant Staphylococcus aureus bacteria. Photo: courtesy of MattKingston.