Recro Pharma Inc (NASDAQ:REPH) is up more than 27% on Wednesday after announcing data from its lead acute pain trial. The company has developed an IV formulation of an already established drug, and is currently enrolling in the second of two pivotals that will form the basis of a New Drug Application if all runs smoothly. Ahead of the completion of the second pivotal, let’s take a look at the drug in question, and see what success in the remainder of the clinical development might mean for Recro.
The drug, Meloxicam, is a non-opioid pain killer (what’s called a nonsteroidal anti-inflammatory drug (NSAID)) and Recro is attempting to get it approved in an acute postoperative pain indication (for this trial, in patients that have had bunionectomy surgery). As mentioned, it’s already a well established drug, having been approved before the turn of the century based on a Boehringer Ingelheim development program. It’s now available as a generic oral administration, but there are some issues with its bioavailabilty. Specifically, it’s Tmax. In drug development, two things are important to measure. Cmax is the peak concentration after dosing – i.e. the time at which the drug is most effective. Tmax is the time it takes to reach Cmax. The Tmax of the currently approved, oral administration Meloxicam is between 5-6 hours. For acute pain in postoperative patients, this isn’t ideal. Patients that have just come out of surgery need rapid onset (i.e. short Tmax) pain relief.
Recro’s formulation of Meloxicam is intravenous (IV) administration, which dramatically reduces the Tmax of the drug.
Why hasn’t this been done before? Well, Meloxicam’s long Tmax is rooted in its poor water solubility. This can be a positive from an abuse deterrent perspective, but it’s a quality doesn’t fit well with an intravenous formulation. Recro has licensed a technology from Alkermes Plc (NASDAQ:ALKS) called NanoCrystal Technology, and used this technology to develop its formulation. The technology reduces the size of the active particles in Meloxicam, which increases the active surface area of the formulation. This increased surface area means an improved dissolution rate, and better bioavailability.
So what did the data tell us?
Basically, the drug works. The trial compared what’s called Summed Pain Intensity Difference (SPID) between patients that received placebo and patients that received the drug, across the 48-hour period immediately post-administration. The 48 hour measurement is called SPID48, for obvious reasons. A stat sig difference in SPID48 between placebo and active was the primary endpoint, and the trial met this endpoint. It also met a bunch of secondary endpoints, including SPID6, SPID12 and SPID24. Safety profile came out clean, with no serious AEs and no bleeding events (which are quite common in IV admin trials).
So that’s the first of the pivotals out of the way, with great topline. There’s a second running, and that’s what we are now looking to as the next milestone before NDA submission. This one’s evaluating IV meloxicam following what’s called mini abdominoplasty surgery (it’s a tummy tuck that focuses on the space below the naval and above the public area), and using the same endpoints as yardsticks of efficacy. As far as we can see, there should be no reason why the drug would work in bunionectomy patients and not in abdominoplasty patients, so there’s a good chance the second phase III will report positive topline come data dump. If and when it does, the company expects to submit an NDA based on data from both trials. That submission is our target catalyst beyond the abdominoplasty topline.
Alongside the latest release, Gerri Henwood, Recro Pharma’s President and Chief Executive Officer, stated that she expects to submit the application (given that everything goes to plan) during mid-summer 2017. That basically gives us a twelve-month period between now and NDA submission, and should mean we see a PDUFA sometime during the first half of 2018.
Both Alkermes and Recro stand to gain from an approval.