AcelRx Pharma (ACRX) Says ARX-04 Phase 3 Met Primary Endpoint in Trauma/Injury Pain Reduction
- Wall St. opens higher as M&A activity boosts confidence
- AT&T (T) to Acquire Time Warner (TWX) for $107.50/Share
- Rockwell Collins (COL) to Acquire B/E Aerospace (BEAV) for $6.4B
- TD Ameritrade (AMTD) to Acquire Scottrade in $4B Cash & Stock Deal
- Pre-Open Stock Movers 10/24: (BEAV) (JPEP) (HLT) Higher; (BAS) (INO) (ADRO) Lower (more...)
Get the Pulse of the Market with StreetInsider.com's Pulse Picks. Get your Free Trial here.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) reported topline results from the single-arm, open-label Phase 3 SAP302 trial (NCT02447848), which assessed ARX-04 (sufentanil sublingual tablet, 30 mcg) in patients who presented to the emergency room with moderate-to-severe acute pain associated with trauma or injury. Overall, the 76 adults treated with ARX-04 in this study experienced a mean pain intensity difference to baseline (PID) of 2.9 from a baseline of 8.1, or 35%, on a 0 – 10 numeric rating scale at 60 minutes.
SAP302 enrolled patients in two cohorts. The initial phase enrolled 40 adults who were administered a single dose of ARX-04; and an extension phase enrolled 36 adults who were eligible to receive up to four doses of ARX-04, given hourly as needed for pain. Interim results from the first cohort were reported in February 2016, and showed that patients treated with a single dose of ARX-04 experienced a mean pain intensity decrease from baseline of 2.7 at 60 minutes. Patients in the second cohort reported a mean pain intensity decrease from baseline of 3.1 on the 0 – 10 pain intensity scale at 60 minutes. Of these 36 patients, seven received a second dose of ARX-04, and two received a third dose. For 75% of patients in the second cohort, a single dose of ARX‑04 was sufficient for pain relief and only 8% of patients received morphine in addition to ARX-04.
In addition, ARX-04 demonstrated a predicted onset of activity in patients enrolled in SAP302. Patients reported a mean pain intensity decrease of 1.1 compared to baseline 15 minutes following first administration of ARX-04, and a decrease of 1.9 after 30 minutes.
Overall ARX-04 was well tolerated in this study, with 79% of patients reporting no adverse events. The most common adverse events reported in the study occurred with single-digit rates - the most common being nausea (9%), somnolence (5%) and vomiting (4%). All these events were rated as mild with the exception of one event of moderate nausea. Drug-induced cognitive impairment was not seen with ARX-04 in this study, as assessed using the validated Six-Item Screener.
"The Department of Defense, which has provided us with development funding for ARX-04, suggested that we conduct a cognitive impairment assessment to determine if ARX-04 causes cognitive deficiencies, which is an understandable concern when treating wounded soldiers on the battlefield," explained Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx Pharmaceuticals. "In addition to putting combat units in danger, drug-induced cognitive effects can impede diagnosis and treatment in a civilian emergency room. If borne out, ARX-04's onset of pain relief, sublingual dosage form and side effect profile could make it an attractive option for doctors considering opioid analgesic treatment in emergency rooms and field-based settings."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- UPDATE: Analogic (ALOG) CEO Green Resigns; Successor Named
- Gilead Sciences (GILD) Announces Results from Studies of Switching HIV-1 Patients to Descovy; Results Statistically non-Inferior
- Ligand Pharma (LGND) Announces Submission of Baxdela NDAs to FDA as ABSSSI Treatment
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!