Technical Analysis
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Heron Therapeutics, Inc. is a company I see potential value in. I have not taken a position; however, this company is currently on my watch list. This company currently has two approved products, SUSTOL® (granisetron) and CINVANTI® (aprepitant). HTX-011 (bupivacaine and meloxicam) is their investigational product that has a Prescription Drug User Fee Act (PDUFA) date of 30 April 2019.
Heron Therapeutics uses a proprietary Biochronomer® drug delivery technology that consists of polymers that undergo controlled hydrolysis, which lead to a slow release of a pharmacological agent.¹ The company’s Biochronomer® drug delivery technology has proved its effectiveness to the FDA with the approval of SUSTOL® (granisetron). The use of this technology for HTX-011 (bupivacaine and meloxicam) may lead to another long-acting local anesthetic product on the market.
HTX-011 is an extended-release (ER), fixed-ratio of bupivacaine, an amide anesthetic, and meloxicam, a non-steroidal anti-inflammatory, that I expect to be indicated for a single dose infiltration in adults to produce postsurgical local analgesia.
SUMMARY
In two prospective randomized, multicenter, double-blind, placebo-controlled, institutional review board-approved phase 2 trials involving subjects undergoing bunionectomy (NCT02762929) or herniorrhaphy (NCT02504580), there was a statistically significant pain relief with HTX-011 compared to either bupivacaine HCl (B) or saline placebo (P) after bunionectomy (60mg) (60mg v P: p = 0.0003; 60 mg v B: p = 0.0166) or herniorrhaphy (300 mg) (300mg v P: p = 0.0045; 300 mg v B: p = 0.0427) through 72 hours.²
Results of these studies with HTX-011 are described below in Table 1.
CLINICAL STUDIES
| Study and Design | Population/Dose | Summary |
| NCT027629292
Prospective randomized, multicenter, double-blind, placebo-controlled, institutional review board-approved phase 2 trial |
N=180 patients enrolled for efficacy evaluation
n=52 (HTX-011 60mg) were administered via injection or instillation for a bunionectomy; mean age=52.2 years; 86.5% F; mean BMI=29.2kg/m2 vs n=25 (bupivacaine HCl 50mg) were administered via injection for a bunionectomy; mean age=52.7 years; 88% F; mean BMI=31.75 kg/m2 vs n=104 (control group) were administered saline placebo for a bunionectomy; mean age=50 years; 87.5% F; mean BMI=30.26 kg/m2 |
HTX-011 provided statistically significantly better pain relief than either bupivacaine HCl (p = 0.016) or saline placebo (p = 0.0003) after bunionectomy (60 mg) through 72 hours.
Mean pain scores after surgery remained below the severe pain threshold after treatment with HTX-011, whereas scores after treatment with bupivacaine and saline placebo both crossed the threshold for severe pain. HTX-011 subjects required significantly less opioid rescue medication (21.73 intravenous morphine milligram equivalents [MMEs]) than subjects receiving bupivacaine HCl (32.28 MMEs, p = 0.0382) or saline placebo (32.65 MMEs, p = 0.0047) after bunionectomy through 72 hours Total opioid rescue medication consumption was numerically lower after herniorrhaphy with HTX-011 (18.38 MMEs) compared with bupivacaine HCl (25.09 MMEs, p = 0.3324) and saline placebo (28.94 MMEs, p = 0.0815) through 72 hours A greater proportion of bunionectomy (B) subjects were opioid-free through 72 hours with HTX-011 treatment than with bupivacaine HCl (17.3% vs 8.0%, p = 0.4877) or saline placebo (17.3% vs 3.9%, p = 0.0106) |
| NCT025045802
Prospective randomized, multicenter, double-blind, placebo-controlled, institutional review board-approved phase 2 trial |
N=133 patients enrolled for efficacy evaluation
n=16 (HTX-011 300mg) were administered via instillation for a herniorrhaphy; mean age=52.2 years; 86.5% F; mean BMI=29.2kg/m2 vs n=32 (bupivacaine HCl 75mg) were administered via injection for a herniorrhaphy; mean age=52.7 years; 88% F; mean BMI=31.75 kg/m2 vs n=85 (control group) were administered saline placebo for a herniorrhaphy; mean age=50 years; 87.5% F; mean BMI=30.26 kg/m2 |
HTX-011 provided significantly better pain relief than either bupivacaine HCl (p = 0.0427) or saline placebo (p = 0.0045) after herniorrhaphy (300 mg) through 72 hours.
Total opioid rescue medication consumption was numerically lower after herniorrhaphy with HTX-011 (18.38 MMEs) compared with bupivacaine HCl (25.09 MMEs, p = 0.3324) and saline placebo (28.94 MMEs, p = 0.0815) through 72 hours A greater proportion of herniorrhaphy (H) subjects were opioid-free through 72 hours with HTX-011 treatment than with bupivacaine HCl (50.0% vs 12.5%, p = 0.0108;) or saline placebo (50.0% vs 7.2%, p = 0.0001) |
REFERENCES
- Ottoboni T et al. Biochronomer™ technology and the development of APF530, a sustained release formulation of granisetron. J Exp Pharmacol. 2014;6:15-21.
- Viscusi E, Minkowitz H, Onel E, Chu A, Patel SS, Ottoboni T, Wilker C, Quart B. Synergistic Effect of the Active Components in HTX-011, a Novel Fixed-ratio Formulation of Bupivacaine and Meloxicam, Across Multiple Doses and Surgical Models. Presented at ASRA Spring 2018, April 2018.
Disclosure: I have no positions in the stock mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions and not of those of my employer. I am not receiving compensation for it. I have no business relationship with the company whose stock is mentioned in this article.
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