On July 2, 2009, King Pharmaceuticals (KG) met with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter regarding the new drug application (NDA) for Remoxy.
King is collaborating with Pain Therapeutics (PTIE) on Remoxy, a unique controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce the potential risks of abuse or misuse. According to King, the outcome of the meeting with the FDA provided a clear path forward to resubmit the Remoxy NDA and address all FDA comments listed in the complete response letter.
Remoxy approval had previously been expected in December 2008; however, the FDA requested additional information relating to long-term (six month) stability of the product prior to granting approval. No new clinical trials will be necessary to satisfy the FDA’s requests.
This is clearly a positive, as during an FDA advisory panel meeting in November 2008, some members suggested that an additional program to evaluate the “abuse-resistance” of the product be conducted. King expects to complete the six-month stability testing and re-file for approval of the drug around mid-2010.
News that King and Pain will be in position to re-file for Remoxy approval is positive for Durect Corp. (DRRX). Remoxy utilizes Durect’s ORADUR, a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of being less prone to abuse through crushing or alcohol or water extraction of the active molecule than other controlled release dosage forms on the market today.
Durect will receive a royalty based on net sales of Remoxy at King at a rate 6% to 11.5%. Our financial model now assumes Remoxy launches in early 2011. We are maintaining our Buy rating and $5 price target on Durect Corp.
Read the full analyst report on “KG”
Read the full analyst report on “PTIE”
Read the full analyst report on “DRRX”
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