
Heron and the Never-Ending FDA Drug Review
Heron Therapeutics (HRTX) - Get Report won't explain why the Food and Drug Administration is taking so long to render an approval decision for Sustol, the company's lead supportive cancer care drug.
It's been one month exactly since Heron announced the start of discussions with the FDA to hammer out the Sustol label. The FDA found "no substantive deficiencies" in Sustol's approval application, Heron also stated in its April 18 press release, even though the agency's original approval decision was supposed to have been announced last January.
Sustol is an injection to reduce nausea and vomiting in cancer patients undergoing chemotherapy. Doctors already have a lot of treatment options for chemotherapy-induced nausea and vomiting (CINV), both branded drugs and cheaper generics.
Heron claims Sustol will work better than current CINV therapies, but that doesn't explain the long delay in what should be a routine, straightforward FDA review process.
"Labeling negotiations are progressing, but unfortunately, I cannot comment further regarding our interactions with the FDA," said Heron spokesperson Jennifer Capuzelo.
An FDA spokesperson declined to answer questions about the status of the Sustol review, citing confidentiality requirements.
Heron's stock price has suffered from Sustol's prolonged and confusing trip through the FDA review process. At $18, Heron shares are down almost 60% from their peak high last September. This year, the stock is down 33%.
The FDA rejected Sustol twice previously before Heron resubmitted the drug again last July. Heron went back to the FDA for a third time based on data from a new Phase III study dubbed "MAGIC" which achieved its primary endpoint, with 65% of cancer patients responding to the Sustol regimen compared to 57% of patients treated with a Zofran-containing regimen, the current standard of care.
The FDA accepted the Sustol resubmission and set an approval decision date of Jan. 17. Here's where the Sustol review process gets weird.
On Jan. 15, Heron said the FDA needed more time to complete the Sustol review, pushing back the approval decision date to "late February."
On Feb. 29, Heron said the FDA needed still more time to review Sustol. No new approval decision was offered.
On March 3, Heron issued yet another Sustol regulatory update, this time claiming that the FDA would complete the review by "early April."
On April 18, Heron said the FDA's Sustol review was still not finished but that labeling discussions had been started. No timeline for an approval decision was provided.
And so, investors wait.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.









