AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) has been riding the rails of the biotech roller coaster perhaps more than any other name over the past 10 days. The story is rooted in an initial misunderstanding of a briefing put out on last Wednesday (October 10) ahead of the key FDA AdCom vote scheduled for last Friday (October 12). It turned out to be highly constructive for the company, and shares took off higher.

The AdCom vote went well: the company announced that the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-3 in favor of recommending the approval of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. Shares leapt higher following the close.

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) is a specialty pharmaceutical company that focuses on the development and commercialization of therapies for the treatment of acute pain. Its lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

DSUVIA (sufentanil sublingual tablet, 30 microgram), known as DZUVEO outside the United States, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients and was designed to eliminate dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) administered by health care professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia.

The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018.

The company also develops ZALVISO, a pre-programmed and patient-controlled analgesia system that allows hospital patients with moderate-to-severe acute pain to self-dose with sufentanil sublingual tablets to manage their pain.

The company was formerly known as SuRx Pharmaceuticals, Inc. and changed its name to AcelRx Pharmaceuticals, Inc. in August 2006. AcelRx Pharmaceuticals, Inc. was founded in 2005 and is headquartered in Redwood City, California.

 

Just Making Sure

ACRX just put out a new communication, noting that it “stands by the safety, efficacy and medical need for its investigational therapy, DSUVIA. Developed in collaboration with the Department of Defense, DSUVIA potentially represents an important non-invasive, rapidly acting alternative to IV opioids, the current standard of care for acute pain management in medically supervised settings.”

ACRX has had a rough past five days of trading action, with shares sinking something like -9% in that time. This is after huge gains the prior week, as noted above.

According to its most recent release, “We appreciate the thoughtful and thorough discussion among the 13 committee members, as well as the forum for public commentary. The Committee voted 10-3 in favor of recommending the approval of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. AcelRx is committed to continued collaboration with the FDA on the new drug application for DSUVIA.”

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) pulled in sales of $818K in its last reported quarterly financials, representing top line growth of -69.2%. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($50.1M against $13.2M).

At the end of the day, to put out a special release noting that the company stands by its drug is clearly a statement meant to target anyone who still is under the spell of the elements in the adcom briefing that caused the confusion in the first place: in the materials, on page 29 of the briefing, the review team stated that the Human Factors Study did not demonstrate that the user interface “supports the safe and effective use of the product”  and “we do not find the risk acceptable.”

However, it later turned out that the real lead story in the briefing was that the company had sufficiently addressed the review team’s concerns over the safety of the 30 mcg tablets at maximum dosing and the risk of misplaced tablets, which suggested that a thumbs up would be forthcoming. The stock launched higher as a result.

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