Unclear Whether FDA Took Into Account KemPharm's Amendment Data in Rejecting Apadaz Application
June 14, 2016
By Mark Terry, BioSpace.com Breaking News Staff
KemPharm , headquartered in Coralville, Iowa, announced today that the U.S. Food and Drug Administration (FDA) had sent a Complete Response Letter (CRL) regarding the company’s New Drug Application (NDA) for Apadaz (benzhydrocodone and acetaminophen).
Apadaz was being investigated for short-term management of acute pain.
On June 9, KemPharm indicated it had sent the FDA an amendment request for the Apadaz NDA. The amendment was to give the FDA more information.
“While the FDA’s provided us with a draft label, we feel that additional information could strengthen the draft, with a focus on the section relating to abuse-deterrent product labeling,” said Travis Mickle, president and chief executive officer of KemPharm, in a statement. “Our discussions with the FDA have been constructive and we are hopeful that we can agree on an approval pathway that includes abuse-deterrent labeling for Apadaz.”
What is not currently clear is whether the FDA took into account the additional information in the amendment request. StreetInsider indicates that the company will need to schedule an End of Review meeting with the FDA to discuss the labeling on Apadaz. “Since the Agency made an amendment request last week, the CRL came as a surprise. Investors are likely assuming the worst since the FDA chose to issue a CRL rather than grant a PDUFA extension. However, KemPharm does not yet know whether the FDA considered the amendment in providing the CRL, or whether the amendment was submitted too late in the review process.”
The company’s overall focus is on developing pain management drugs and combinations. On March 28, the company announced that its Investigational New Drug (IND) application for KP511, a prodrug of hydromorphone, had been accepted by the FDA. KP511 is being developed as an abuse-deterrent, extended-release (ER) prodrug to management severe pain that requires daily, 24/7 long-term opioid treatment where other treatments don’t work. Human clinical trials are expected to begin in the second quarter of 2016.
In terms of Apadaz, if the FDA decides there’s a path forward for the drug regarding its labeling, the agency will then have to decide whether a Class I or Class II minor or major review is required for resubmissions. A Class I resubmission has about a two-month timeframe. A Class II resubmission takes about six months.
took a hit at the news. Shares traded for $23.63 on Sept. 18, 2015, dropped to $14.98 on Feb. 1, 2016, then rose to $18.50 on April 22. Shares plunged to $5.87 on May 15 and are currently trading for $4.62 per share.
Earlier today the company had an investor conference call related to its third-quarter financial filings. Mickle said, “As many of you are aware, we completed the second intranasal abuse liability study and with that concluded our planned studies that will go into our NDA for KP201. That particular NDA is right on track to be filed this quarter. That study in particular demonstrated the positive benefits of KP201 in our final, to-be-marketed formulation for acetaminophen. … We are still right on track to provide proof of concept data for KP511, our prodrug of hydromorphone. That’s our next product in our pipeline with now an anticipated NDA date to be filed in 2018.”
The company also expects proof of concept data for KP415, a prodrug methylphenidate and an anticipated NDA for 2019. It is also working on an immediate-release version of oxycodone named KP606 that expects to have proof-of-concept in 2017 and an NDA in 2019.